Tagrisso

(Osimertinib)

ApprovedSmall molecule

Osimertinib is used to treat certain types of lung cancer, specifically non-small cell lung cancer that has specific genetic mutations. It works by blocking proteins that help cancer cells grow.[2] Tagrisso is currently approved and in use across 48 indications[4].[1]

Tagrisso is one of 913 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Approved.

Indications

228

Total Trials

119

Active Trials

912

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Small Cell Lung CancerRecruiting

Breast CancerApproved

Breast CarcinomaApproved

MelanomaApproved

Colorectal CancerApproved

Brain NeoplasmApproved

Lung NeoplasmApproved

ChemotherapyRecruiting

Safety and EfficacyActive, not recruiting

OsimertinibCompleted

Non-Small Cell Lung CancerApproved

Recruiting

Breast CancerApproved

Approved

Breast CarcinomaApproved

Approved

MelanomaApproved

Approved

Colorectal CancerApproved

Approved

Brain NeoplasmApproved

Approved

Lung NeoplasmApproved

Approved

ChemotherapyPhase 2

Recruiting

Safety and EfficacyPhase 2

Active, not recruiting

OsimertinibApproved

Completed

Showing 10 of 48 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tagrisso

Adenocard

2 3

Lexiscan

Astellas

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Acupan

YYonsei University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Erectile Dysfunction

NCT06532149

Q4 2026

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03433469

Phase 1Not yet recruiting

Osimertinib

NCT06067776

Phase 2Recruiting

Chemotherapy

NCT05281406

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT06391944

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT04545710

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer72 trials

Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

Recruiting·HHunan Province Tumor Hospital·Phase 2·NCT04322890·6,000 enrolled

Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting·WWashington University School of Medicine·Phase 1/2·NCT04743505·27 enrolled

The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04179890·462 enrolled

Show 69 more trials

JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations

Not yet recruiting·SShanghai JMT-Bio Inc.·Phase 3·NCT06380348·398 enrolled

JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations

Active, not recruiting·SShanghai JMT-Bio Inc.·Phase 2·NCT06391944·161 enrolled

Osimertinib Combined With Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Metastatic Non-Small Cell Lung Cancer

Unknown status·QQingdao Central Hospital·Phase 2·NCT04974879·20 enrolled

Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Withdrawn·KKura Oncology, Inc.·Phase 1·NCT05693090

Osimertinib With or Without Bevacizumab for EGFR- Mutant Non-small Cell Lung Cancer With Leptomeningeal Metastasis

Unknown status·SSecond Affiliated Hospital of Nanchang University·Phase 2·NCT04148898·80 enrolled

Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Completed·QQingdao Central Hospital·Phase 2/3·NCT02959749·147 enrolled

First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting

Unknown status·FFirst Affiliated Hospital of Zhejiang University··NCT04391283·500 enrolled

Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive

Completed·FFundación GECP··NCT03790397·169 enrolled

Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance

Active, not recruiting·UUniversity of California, San Diego·Phase 2·NCT04545710·18 enrolled

Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery

Active, not recruiting·UUniversity of California, San Francisco·Phase 2·NCT03433469·27 enrolled

Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations

Active, not recruiting· AstraZeneca logo

AstraZeneca··NCT05103605·274 enrolled

Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02520778·27 enrolled

A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations

Recruiting·SShanghai JMT-Bio Inc.·Phase 3·NCT06735391·516 enrolled

Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy

Terminated· Novartis logo

Novartis·Phase 3·NCT04816214·6 enrolled

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06417814·744 enrolled

Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer

Unknown status·SShanghai JMT-Bio Inc.··NCT05513664·80 enrolled

Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer

Unknown status·QQingdao Central Hospital·Phase 3·NCT05104281·60 enrolled

A Study to Evaluate the Efficacy of Osimertinib in Patients With EGFR-sensitive Mutated Non-small Cell Lung Cancer Progression After Receiving Adjuvant Targeted Therapy Following Radical Surgery

Not yet recruiting·JJin Ying·Phase 2·NCT06530719·54 enrolled

A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05880706·198 enrolled

A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs

Recruiting·SShanghai JMT-Bio Inc.·Phase 3·NCT06829459·350 enrolled

A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer

Recruiting· Shanghai Hengrui Pharmaceutical Co., Ltd. logo

Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 2·NCT07229729·300 enrolled

Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

Terminated·EEQRx International, Inc.·Phase 3·NCT05493501·8 enrolled

Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer

Unknown status·SShanghai JMT-Bio Inc.·Phase 2·NCT05132777·155 enrolled

Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT05085054·30 enrolled

VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer

Unknown status·JJiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.·Phase 1·NCT05489731·72 enrolled

Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06525246·78 enrolled

Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer

Recruiting·—·Phase 2·NCT07379476·64 enrolled

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer

Active, not recruiting·—·Phase 1·NCT05166616·8 enrolled

SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2/3·NCT05020769·14 enrolled

Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02503722·36 enrolled

MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer

Recruiting·EEmory University·Phase 1·NCT04762199·69 enrolled

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer

Active, not recruiting·VVestre Viken Hospital Trust·Phase 2·NCT03804580·100 enrolled

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT02664935·423 enrolled

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting·XXiuning Le·Phase 2·NCT03909334·160 enrolled

HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04676477·246 enrolled

A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 2·NCT07256509·120 enrolled

Osimertinib With Bevacizumab for Leptomeningeal Metastasis From EGFR-mutation Non-Small Cell Lung Cancer

Unknown status·SSecond Affiliated Hospital of Nanchang University·Phase 2·NCT04425681·20 enrolled

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

Active, not recruiting·KKlus Pharma Inc.·Phase 2·NCT05816252·356 enrolled

A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations

Completed·—·Phase 2·NCT03434418·17 enrolled

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06838273·720 enrolled

Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05642572·66 enrolled

An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

Completed· Incyte logo

Incyte·Phase 1/2·NCT02917993·59 enrolled

Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02759835·37 enrolled

Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

Recruiting·TTYK Medicines, Inc·Phase 3·NCT05382728·680 enrolled

DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

Terminated· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03255083·13 enrolled

G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

Completed·GG1 Therapeutics, Inc.·Phase 1/2·NCT03455829·30 enrolled

Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations

Terminated·CChul Kim·Phase 1/2·NCT02954523·10 enrolled

Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer

Not yet recruiting·JJianxing He·Phase 2·NCT07177092·118 enrolled

Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT04479306·37 enrolled

Study of Osimertinib+Bevacizumab+Chemotherapy for EGFR+ Advanced Non-Small Cell Lung Cancer With Concurrent Mutations

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05507606·50 enrolled

A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations

Unknown status·YYonsei University·N/A·NCT04816838·25 enrolled

Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT06093503

Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)

Not yet recruiting·FFudan University·Phase 3·NCT06323148·226 enrolled

Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06363734·32 enrolled

A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06498986·40 enrolled

Combination of Osimertinib and Aspirin to Treat Osimertinib Resistance Non-small Cell Lung Cancer ( NSCLC)

Unknown status·—··NCT03532698·100 enrolled

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

Recruiting·NNational Cancer Center, China·Phase 1·NCT06362980·20 enrolled

A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT07155187·490 enrolled

A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04351555·358 enrolled

Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients

Active, not recruiting·PPrECOG, LLC.··NCT06538038·200 enrolled

A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04035486·587 enrolled

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07622186·150 enrolled

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Preclinical·NCT07079475·220 enrolled

Biomarker-Directed Treatment in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC: A Prospective, Multi-cohort, Interventional Study (REVIVE)

Recruiting· AstraZeneca logo

AstraZeneca·Approved·NCT07279935·100 enrolled

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06350097·582 enrolled

A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

Not yet recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07680790·850 enrolled

A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT03940703·140 enrolled

A Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07329322·30 enrolled

Osimertinib20 trials

Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

Completed·SShanghai Chest Hospital·Phase 1/2·NCT04770688·25 enrolled

A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC

Recruiting·SShanghai Chest Hospital·Phase 2·NCT07058519·250 enrolled

Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

Completed·SSeoul National University Hospital·Phase 2·NCT03414814·15 enrolled

Show 17 more trials

Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03778229·367 enrolled

Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05686434·65 enrolled

Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC

Active, not recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT03667820·41 enrolled

Osimertinib Study in Indian Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT03853551·60 enrolled

Osimertinib With or Without Savolitinib as 1L in de Novo MET+, EGFR+ NSCLC

Active, not recruiting·GGuangdong Association of Clinical Trials·Phase 2·NCT05163249·44 enrolled

Boosting Osimertinib Blood Brain Barrier Penetration

Not yet recruiting·MMaastricht University Medical Center·Phase 2·NCT07485452·7 enrolled

A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients

Active, not recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1·NCT04001777·80 enrolled

Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment

Terminated·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT04438902·3 enrolled

Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients

Not yet recruiting·GGruppo Oncologico Italiano di Ricerca Clinica··NCT07363252·100 enrolled

Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC

Completed· AstraZeneca logo

AstraZeneca··NCT03133234·47 enrolled

Afatinib Osimertinib Sequencing NIS

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03370770·204 enrolled

Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

Not yet recruiting·JJonathan Riess·Phase 1·NCT06067776·36 enrolled

Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC

Unknown status·PPeking Union Medical College·Phase 2·NCT05458726·80 enrolled

Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 4·NCT05785208·122 enrolled

Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC

Completed·—·Phase 2·NCT03543683·115 enrolled

Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

Recruiting·IInstituto Oncológico Dr Rosell·Phase 1·NCT04772235·32 enrolled

Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT02856893·156 enrolled

Lung Cancer18 trials

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

Recruiting·RRegion Skane·Phase 3·NCT06486142·200 enrolled

A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03755102·17 enrolled

Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Active, not recruiting·—·Phase 1/2·NCT03122717·48 enrolled

Show 15 more trials

A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02789345·29 enrolled

Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)

Completed·UUniversity Hospital, Essen·Phase 2·NCT03810066·16 enrolled

Osimertinib In EGFR Mutant Lung Cancer

Recruiting·—·Phase 2·NCT03586453·30 enrolled

Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer

Unknown status·SSun Yat-sen University·Phase 2·NCT03460275·100 enrolled

Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge

Recruiting·MMark Vincent·Phase 2·NCT04335292·200 enrolled

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03944772·247 enrolled

EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer

Unknown status·SShanghai EpimAb Biotherapeutics Co., Ltd.·Phase 1/2·NCT05498389·115 enrolled

Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06752408·316 enrolled

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03810807·22 enrolled

Study of Osimertinib in Patients with a Lung Cancer with Brain or Leptomeningeal Metastases with EGFR Mutation

Completed·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT04233021·57 enrolled

Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Unknown status·MMassachusetts General Hospital·Phase 1·NCT03891615·30 enrolled

Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT02803203·49 enrolled

A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06741085·56 enrolled

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT06618287·416 enrolled

A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06194448·76 enrolled

Brain Metastases7 trials

Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

Active, not recruiting·BBritish Columbia Cancer Agency·Phase 2·NCT03769103·40 enrolled

Almonertinib Versus Osimertinib in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

Unknown status·SShanghai Chest Hospital·Phase 3·NCT04870190·232 enrolled

Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases: A Retrospective Real-World Study

Active, not recruiting·FFudan University··NCT07491211·300 enrolled

Show 4 more trials

High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases

Not yet recruiting·TTaizhou Hospital·Phase 2·NCT06319950·255 enrolled

Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03463525·4 enrolled

A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases

Completed·TTrans Tasman Radiation Oncology Group·Phase 2·NCT03497767·40 enrolled

Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC

Completed·—·Phase 1·NCT03535363·6 enrolled

EGFR Mutation5 trials

Combination of Osimertinib and Aspirin to Treat EGFR Mutation NSCLC Patients

Completed·—·Phase 2·NCT04184921·216 enrolled

Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)

Recruiting·SSamsung Medical Center·Phase 2·NCT04591002·43 enrolled

Osimertinib in First and Second Line Treatment of NSCLC Harboring EGFR Mutations From Circulating Tumor DNA

Completed·—·Phase 2·NCT02769286·38 enrolled

Show 2 more trials

Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations

Unknown status·FFondazione Ricerca Traslazionale·Phase 2·NCT04811001·170 enrolled

T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC

Terminated·TThe Netherlands Cancer Institute·Phase 2·NCT03784599·28 enrolled

55 more indications

Locally Advanced or Metastatic NSCLC5 trials

Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Recruiting·AAvistone Biotechnology Co., Ltd.·Phase 2·NCT06574347·120 enrolled

BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations

Terminated·LLianBio LLC·Phase 1·NCT06032936·4 enrolled

Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M

Completed·MMedSIR·Phase 2·NCT02841579·22 enrolled

Show 2 more trials

A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07376382·450 enrolled

A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT03239340·154 enrolled

Advanced NSCLC4 trials

Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC

Active, not recruiting·NNational Cancer Center, China·Phase 2·NCT06827145·30 enrolled

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

Completed·EErasca, Inc.·Phase 1·NCT04959981·24 enrolled

Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations

Active, not recruiting·LLi Zhang, MD·Phase 3·NCT04695925·294 enrolled

Show 1 more trial

A Prospective Study of Pembrolizumab Combining Chemotherapy in Advanced NSCLC Patients With EGFR Exon 21 Point Mutation.

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06142617·37 enrolled

Safety and Efficacy3 trials

A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC

Recruiting·WWayshine Biopharm, Inc.·Phase 1/2·NCT07206498·48 enrolled

Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

Active, not recruiting·UUniversity of Utah·Phase 1·NCT04141644·24 enrolled

Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

Active, not recruiting·AAIO-Studien-gGmbH·Phase 2·NCT05089916·42 enrolled

Chemotherapy3 trials

Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT05215951·4 enrolled

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Recruiting·SSun Yat-sen University·Phase 2·NCT05011487·30 enrolled

Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)

Recruiting·GGoethe University·Phase 2·NCT05281406·50 enrolled

Advanced Solid Tumors3 trials

A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors

Recruiting· Shanghai Hengrui Pharmaceutical Co., Ltd. logo

Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 2·NCT06895928·400 enrolled

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT02099058·237 enrolled

Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors

Terminated·IIkena Oncology·Phase 1·NCT05228015·67 enrolled

Efficacy and Safety2 trials

AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC

Active, not recruiting·MMichael Hopp·Phase 4·NCT04413201·34 enrolled

Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

Completed· AstraZeneca logo

AstraZeneca··NCT03219970·156 enrolled

NSCLC2 trials

(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC

Terminated·BBlueprint Medicines·Phase 1·NCT05153408·20 enrolled

A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases

Recruiting·TTYK Medicines, Inc·Phase 2·NCT05948813·420 enrolled

Lung Adenocarcinoma2 trials

Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma

Not yet recruiting·TThe University of Hong Kong·Phase 2·NCT06918782·47 enrolled

Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

Recruiting·SSamsung Medical Center·Phase 2·NCT05528458·59 enrolled

Small Cell Lung Cancer2 trials

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Not yet recruiting·MMisty Shields·Phase 1/2·NCT07153055·16 enrolled

Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer

Not yet recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07323641·60 enrolled

Neoadjuvant Therapy2 trials

A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

Not yet recruiting·WWen-zhao ZHONG·Phase 2·NCT07038460·134 enrolled

Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.

Not yet recruiting·—·Phase 2·NCT06018688·44 enrolled

Advanced Lung Non-Small Cell Carcinoma2 trials

Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03191149·46 enrolled

A Phase Ib Study of Osimertinib (AZD9291) and Telaglenastat (CB-839) HCl in Patients With EGFR Mutant Non-Small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT03831932·22 enrolled

Lung Non-Small Cell Carcinoma2 trials

Randomized Phase II Trial of Osimertinib With or Without Local Consolidation Therapy (LCT) for Patients With EGFR-Mutant Metastatic NSCLC (NORTHSTAR)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03410043·173 enrolled

Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma

Suspended·CCity of Hope Medical Center·Phase 2·NCT06014827·32 enrolled

Advanced Lung Non-Squamous Non-Small Cell Carcinoma2 trials

A Phase Ib/II Trial to Evaluate Safety, Tolerability and Efficacy of Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for Patients With EGFR-Mutant Non-Small Cell Lung Cancer

Completed·MM.D. Anderson Cancer Center·Preclinical·NCT05017025·32 enrolled

Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04181060·300 enrolled

Carcinoma, Non-Small-Cell Lung2 trials

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer

Recruiting·GGenprex, Inc.·Preclinical·NCT04486833·158 enrolled

A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04487080·1,074 enrolled

Advanced Lymphoma2 trials

MATCH Treatment Subprotocol E: Osimertinib (AZD9291) in Patients With Tumors Having EGFR T790M Mutations or Rare Activating Mutations of EGFR

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06303167·19 enrolled

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Uncommon EGFR Mutations1 trial

Osimertinib for NSCLC With Uncommon EGFR Mutations

Suspended·SSheba Medical Center··NCT05421936·100 enrolled

Cognition1 trial

Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI

Unknown status·SSun Yat-sen University·Phase 2·NCT04829019·88 enrolled

Prospective1 trial

First Line Osimertinib in the Real World: an Inter-regional Prospective Study

Completed·IIstituto Oncologico Veneto IRCCS··NCT04965701·200 enrolled

Stage IV NSCLC1 trial

SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Unknown status·LLi Zhang·N/A·NCT05583409·72 enrolled

Combination Therapy1 trial

CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC

Not yet recruiting·SSecond Affiliated Hospital of Nanchang University·Phase 1·NCT06557096·100 enrolled

Solid Tumors1 trial

First in Human Study of AZD9592 in Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT05647122·403 enrolled

Treatment1 trial

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting·PPeking University Shenzhen Hospital·Phase 2·NCT06692491·200 enrolled

Metastatic NSCLC1 trial

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT02411448·545 enrolled

Resistance1 trial

(SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC

Terminated·BBlueprint Medicines·Phase 1·NCT04862780·177 enrolled

Neoadjuvant1 trial

Neo-Bio-ADAURA: a Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib

Recruiting·JJair Bar, M.D., Ph.D.·Phase 2·NCT06206850·20 enrolled

Tics1 trial

A Study to Assess the Effect of Food on the Pharmacokinetics of TY-9591 in Healthy Volunteers

Completed·TTYK Medicines, Inc·Phase 1·NCT04798638·16 enrolled

Radiotherapy1 trial

Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)

Terminated·EETOP IBCSG Partners Foundation·Phase 2·NCT04908956·6 enrolled

Leptomeningeal Metastasis1 trial

Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer

Recruiting·GGuangzhou Medical University·N/A·NCT06304441·100 enrolled

Patients With Advanced Solid Tumors1 trial

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Completed·AAllist Pharmaceuticals, Inc.·Phase 1/2·NCT04720976·58 enrolled

Real-world Study1 trial

Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study

Unknown status·GGuangdong Association of Clinical Trials··NCT04575415·272 enrolled

Minimal Residual Disease1 trial

Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

Not yet recruiting·GGuangdong Association of Clinical Trials·N/A·NCT06709274·342 enrolled

Liquid Biopsy1 trial

TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy

Completed·—·Phase 2·NCT03394118·63 enrolled

Unresectable1 trial

Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study

Not yet recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07295821·60 enrolled

Bispecific Antibody1 trial

Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination

Active, not recruiting·MMerus B.V.·Phase 1/2·NCT04868877·194 enrolled

Metastatic Solid Tumors1 trial

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Recruiting·VVivace Therapeutics, Inc·Phase 1/2·NCT04665206·336 enrolled

Metastatic Colorectal Cancer1 trial

Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer

Completed· Roche logo

Roche·Phase 1·NCT05954871·10 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Bevacizumab1 trial

Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC

Unknown status·GGuangdong Association of Clinical Trials·Phase 2·NCT04988607·90 enrolled

Relapsed/Refractory1 trial

Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT04721015·81 enrolled

Pancreatic Cancer1 trial

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06630325·30 enrolled

Advanced/Metastatic Solid Tumors1 trial

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

Recruiting·DDualityBio Inc.·Phase 1/2·NCT05785741·1,000 enrolled

First-line Treatment1 trial

Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC

Not yet recruiting·—·Phase 2·NCT06436144·93 enrolled

Glioblastoma1 trial

18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients with EGFR Activated Recurrent Glioblastoma

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT03732352·12 enrolled

Squamous Cell Carcinoma1 trial

Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

Recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT06383728·51 enrolled

Sacituzumab Tirumotecan1 trial

A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib Monotherapy

Recruiting·GGuangdong Association of Clinical Trials·Phase 2·NCT07375316·120 enrolled

Solid Tumours1 trial

Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02923947·16 enrolled

Metastatic Lung Non-Small Cell Carcinoma1 trial

A Phase Ib Study of AZD9291 (Osimertinib) and BC2059 (Tegavivint) as First-Line Therapy in Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 1·NCT04780568·25 enrolled

Metastatic Non Small Cell Lung Cancer1 trial

A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients With Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04410796·571 enrolled

Non-small Cell Lung Cancer Stage III1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07640789·418 enrolled

Solid Tumor1 trial

An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT03040973·29 enrolled

Non-Small Cell Lung Carcinoma1 trial

A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy

Recruiting·NNational Taiwan University Hospital·Phase 3·NCT07738172·154 enrolled

Non-small Cell Lung Cancer (NSCLC)1 trial

A Phase II, Open-label, Single-arm, Multi-centre Study to Evaluate the Safety and Efficacy of Osimertinib With Amivantamab as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (OSTARA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05801029·60 enrolled

Solid Tumor, Adult1 trial

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Active, not recruiting·KKumquat Biosciences Inc.·Phase 1·NCT06507306·92 enrolled

Non Small Cell Lung Cancer Metastatic1 trial

A Randomised Phase II Trial of Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT03133546·155 enrolled

Locally Advanced Lung Non-Small Cell Carcinoma1 trial

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

Recruiting·NNRG Oncology·Phase 3·NCT05624996·474 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 13, 2015

TAGRISSO

NDA NDA208065

Sources

References

[1]
ClinicalTrials.gov — 228 trial records for Osimertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tagrisso drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Osimertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Osimertinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208065). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tagrisso. U.S. Food & Drug Administration.
[7]
PubMed — 10 publications indexed for Osimertinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: EGFR Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Patent Landscape[6]

Patent Cliff

Jul 25, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9732058Jul 25, 2032

11524951Jul 25, 2032

8946235Aug 8, 2032

10183020Jan 2, 2035

12465608Nov 26, 2042

Key Publications[7]

Photodynamic therapy based on indomethacin-conjugated photosensitizers: targeting cyclooxygenase-2 in cancer treatment.

Med Gas ResDec 1, 2026DOI: 10.4103/mgr.MEDGASRES-D-25-00210

Roles of gas molecules and related factors in knee cartilage injury and repair: a bibliometric visualization analysis of research hotspots.

Med Gas ResDec 1, 2026DOI: 10.4103/mgr.MEDGASRES-D-26-00163

Protocols in the therapeutic use of medical ozone: a matter of debate.

Med Gas ResDec 1, 2026DOI: 10.4103/mgr.mgr_15_23

Temperature Safeguards and Peri-Procedural Strategies for Stem Cell Collection in Cold Agglutinin Disease: A Case Report and Literature Review.

J Clin ApherAug 1, 2026DOI: 10.1002/jca.70158

Melatonin Modulates Behavioral and Physiological Responses in a Concentration-dependent Manner in a Pilocarpine-induced Seizure-like Model Using Zebrafish Larvae.

Neurotox ResJul 24, 2026DOI: 10.1007/s12640-026-00812-3

Intravenous placenta-derived mesenchymal stem cells enhance early survival as an adjunct to supportive care in severe burn: a preclinical study.

Stem Cell Res TherJul 24, 2026DOI: 10.1186/s13287-026-05053-x

Identifying the angiogenic receptor expression in mantle cell lymphoma patients and murine models.

Biomark ResJul 24, 2026DOI: 10.1186/s40364-026-00975-3

Tear fluid Calcitonin gene-related peptide in patients with idiopathic intracranial hypertension headache - a prospective case-control study.

J Headache PainJul 24, 2026DOI: 10.1186/s10194-026-02453-5

Emergence of feline sporotrichosis with zoonotic risk in a municipality of the Eastern Amazon, Brazil.

Companion Anim Health GenetJul 24, 2026DOI: 10.1186/s40575-026-00156-3

Integration of ATAC-seq and RNA-seq analysis identifies host genes related with PRRSV infection.

Vet ResJul 23, 2026DOI: 10.1186/s13567-026-01804-z

Tagrisso

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Non-Small Cell Lung Cancer72 trials

Osimertinib20 trials

Lung Cancer18 trials

Brain Metastases7 trials

EGFR Mutation5 trials

Locally Advanced or Metastatic NSCLC5 trials

Advanced NSCLC4 trials

Safety and Efficacy3 trials

Chemotherapy3 trials

Advanced Solid Tumors3 trials

Efficacy and Safety2 trials

NSCLC2 trials

Lung Adenocarcinoma2 trials

Small Cell Lung Cancer2 trials

Neoadjuvant Therapy2 trials

Advanced Lung Non-Small Cell Carcinoma2 trials

Lung Non-Small Cell Carcinoma2 trials

Advanced Lung Non-Squamous Non-Small Cell Carcinoma2 trials

Carcinoma, Non-Small-Cell Lung2 trials

Advanced Lymphoma2 trials

Uncommon EGFR Mutations1 trial

Cognition1 trial

Prospective1 trial

Stage IV NSCLC1 trial

Combination Therapy1 trial

Solid Tumors1 trial

Treatment1 trial

Metastatic NSCLC1 trial

Resistance1 trial

Neoadjuvant1 trial

Tics1 trial

Radiotherapy1 trial

Leptomeningeal Metastasis1 trial

Patients With Advanced Solid Tumors1 trial

Real-world Study1 trial

Minimal Residual Disease1 trial

Liquid Biopsy1 trial

Unresectable1 trial

Bispecific Antibody1 trial

Metastatic Solid Tumors1 trial

Metastatic Colorectal Cancer1 trial

Erectile Dysfunction1 trial

Bevacizumab1 trial

Relapsed/Refractory1 trial

Pancreatic Cancer1 trial

Advanced/Metastatic Solid Tumors1 trial

First-line Treatment1 trial

Glioblastoma1 trial

Squamous Cell Carcinoma1 trial

Sacituzumab Tirumotecan1 trial

Solid Tumours1 trial

Metastatic Lung Non-Small Cell Carcinoma1 trial

Metastatic Non Small Cell Lung Cancer1 trial

Non-small Cell Lung Cancer Stage III1 trial

Solid Tumor1 trial

Non-Small Cell Lung Carcinoma1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

Solid Tumor, Adult1 trial

Non Small Cell Lung Cancer Metastatic1 trial

Locally Advanced Lung Non-Small Cell Carcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

Related News