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 30 indications[4].[1]

Tagrisso is one of 629 small molecule programs targeting Erectile Dysfunction. It is currently in Approved.

Indications

223

Total Trials

121

Active Trials

628

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Erectile DysfunctionActive, not recruiting

Lung CancerActive, not recruiting

Non-Small Cell Lung AdenocarcinomaApproved

CognitionActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Breast CarcinomaApproved

Lung NeoplasmApproved

Lung AdenocarcinomaActive, not recruiting

Brain NeoplasmApproved

Non-Small Cell Lung CancerActive, not recruiting

Erectile DysfunctionPreclinical

Active, not recruiting

Lung CancerPhase 3

Active, not recruiting

Non-Small Cell Lung AdenocarcinomaApproved

Approved

CognitionPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 1

Active, not recruiting

Breast CarcinomaApproved

Approved

Lung NeoplasmApproved

Approved

Lung AdenocarcinomaPhase 2

Active, not recruiting

Brain NeoplasmApproved

Approved

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Showing 10 of 30 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tagrisso

AstraZeneca

Approved

223 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

MS Contin

Merck & Co.

Preclinical

2 4

Zolymbus

AbbVie

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 9

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 10

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06498986

Phase 1Active, not recruiting

Advanced Solid Tumors

NCT02099058

Phase 2Active, not recruiting

Osimertinib

NCT05163249

Phase 1/2Recruiting

Advanced/metastatic Solid Tumors

NCT05785741

N/ARecruiting

Leptomeningeal Metastasis

NCT06304441

Phase 2Not yet recruiting

Neoadjuvant Therapy

NCT06018688

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer75 trials

A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05801029·60 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

Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

Not yet recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07329322·60 enrolled

Show 72 more trials

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04035486·587 enrolled

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

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

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

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

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

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

Recruiting·—·Phase 2·NCT07379476·64 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

A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases

Recruiting·AAllist Pharmaceuticals, Inc.·Phase 3·NCT06970639·380 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

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

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

Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT03831932·22 enrolled

Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 1·NCT04780568·24 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

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 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

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

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

Unknown status·—··NCT03532698·100 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

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

Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT04285671·30 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

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

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

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

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

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05261399·324 enrolled

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

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

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

Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

Recruiting·—·Phase 1·NCT05401110·60 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

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

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT03521154·216 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 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

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

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

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

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

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

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

Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)

Completed·SSamsung Medical Center·Phase 2·NCT04563871·73 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

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

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

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

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04351555·358 enrolled

Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study

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

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

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

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

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

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

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

Completed·FFundación GECP··NCT03790397·169 enrolled

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06350097·582 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

Lung Cancer21 trials

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

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

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

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

Show 18 more trials

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

Recruiting·MMark Vincent·Phase 2·NCT04335292·200 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 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 Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

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

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

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

A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Active, not recruiting·—·Phase 2·NCT03392246·25 enrolled

Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

Recruiting·CCollin Blakely·Phase 1·NCT04085315·38 enrolled

Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers

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

Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib

Recruiting·GGenprex, Inc.·Phase 1/2·NCT04486833·158 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

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

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

Osimertinib In EGFR Mutant Lung Cancer

Recruiting·—·Phase 2·NCT03586453·30 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

The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer

Not yet recruiting·HHunan Province Tumor Hospital·Phase 2·NCT06477055·60 enrolled

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

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

Osimertinib20 trials

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

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03778229·367 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

Show 17 more trials

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

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

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

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

Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

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

Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

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

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

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

Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

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

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

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

Brain Metastases8 trials

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

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 5 more trials

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

Completed·—·Phase 1·NCT03535363·6 enrolled

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

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

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

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

Chemotherapy6 trials

Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT05215951·4 enrolled

Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.

Not yet recruiting· AstraZeneca logo

AstraZeneca·Phase 4·NCT07279935·100 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

Show 3 more trials

Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib

Active, not recruiting·BBeijing Cancer Prevention & Treatment Society·Phase 2·NCT04769388·80 enrolled

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

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

Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

Recruiting·PPrECOG, LLC.··NCT06538038·538 enrolled

45 more indications

Advanced NSCLC6 trials

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

A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04606771·30 enrolled

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

Show 3 more trials

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Phase 1/2·NCT07079475·200 enrolled

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

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

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

Locally Advanced or Metastatic NSCLC5 trials

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

Completed·MMedSIR·Phase 2·NCT02841579·22 enrolled

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

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

Show 2 more trials

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

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

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

EGFR Mutation5 trials

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

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

Show 2 more trials

Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations

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

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

Completed·—·Phase 2·NCT02769286·38 enrolled

Efficacy and Safety3 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

Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05546866·51 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

Treatment3 trials

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT03040973·29 enrolled

Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)

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

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

Safety and Efficacy3 trials

Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study

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

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

Lung Adenocarcinoma2 trials

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

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

Small Cell Lung Cancer2 trials

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

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

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

Non-Small Cell Lung Carcinoma2 trials

A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05526755·188 enrolled

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

Recruiting·—·Phase 2·NCT06014827·32 enrolled

Solid Tumors1 trial

First in Human Study of AZD9592 in Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT05647122·403 enrolled

Uncommon EGFR Mutations1 trial

Osimertinib for NSCLC With Uncommon EGFR Mutations

Suspended·SSheba Medical Center··NCT05421936·100 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

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

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

Liquid Biopsy1 trial

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

Completed·—·Phase 2·NCT03394118·63 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

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

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

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

NSCLC1 trial

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

Terminated·BBlueprint Medicines·Phase 1·NCT05153408·20 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

Resectable NSCLC1 trial

To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06194448·76 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

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

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

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

Prospective1 trial

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

Completed·IIstituto Oncologico Veneto IRCCS··NCT04965701·200 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

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

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

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

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

Bevacizumab1 trial

Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC

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

Second-line Treatment1 trial

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

Advanced Solid Malignancies1 trial

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Recruiting·KKumquat Biosciences Inc.·Phase 1·NCT06507306·100 enrolled

Cognition1 trial

Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI

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

Regulatory

FDA Approval Timeline[5]

Nov 13, 2015

TAGRISSO

NDA NDA208065

Sources

References

[1]
ClinicalTrials.gov — 223 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 — 3 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]

Osimertinib as First-Line Treatment in CNS Metastatic NSCLC

J Clin OncolMay 8, 2023DOI: 10.1200/JCO.22.02746

Osimertinib Plus Chemotherapy in EGFR-Mutated NSCLC: FLAURA2

N Engl J MedOct 20, 2022DOI: 10.1056/NEJMoa2210985

Adjuvant Osimertinib in EGFR-Mutated NSCLC: ADAURA Overall Survival

N Engl J MedNov 25, 2021DOI: 10.1056/NEJMoa2114260

Tagrisso

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Non-Small Cell Lung Cancer75 trials

Lung Cancer21 trials

Osimertinib20 trials

Brain Metastases8 trials

Chemotherapy6 trials

Advanced NSCLC6 trials

Locally Advanced or Metastatic NSCLC5 trials

EGFR Mutation5 trials

Efficacy and Safety3 trials

Advanced Solid Tumors3 trials

Treatment3 trials

Safety and Efficacy3 trials

Lung Adenocarcinoma2 trials

Small Cell Lung Cancer2 trials

Neoadjuvant Therapy2 trials

Non-Small Cell Lung Carcinoma2 trials

Solid Tumors1 trial

Uncommon EGFR Mutations1 trial

Relapsed/Refractory1 trial

Erectile Dysfunction1 trial

Neoadjuvant1 trial

Liquid Biopsy1 trial

Solid Tumours1 trial

Tics1 trial

Leptomeningeal Metastasis1 trial

Unresectable1 trial

NSCLC1 trial

Metastatic Solid Tumors1 trial

Resectable NSCLC1 trial

Metastatic NSCLC1 trial

Resistance1 trial

Patients With Advanced Solid Tumors1 trial

Real-world Study1 trial

Minimal Residual Disease1 trial

Metastatic Colorectal Cancer1 trial

Stage IV NSCLC1 trial

Combination Therapy1 trial

Prospective1 trial

Bispecific Antibody1 trial

Sacituzumab Tirumotecan1 trial

First-line Treatment1 trial

Glioblastoma1 trial

Squamous Cell Carcinoma1 trial

Pancreatic Cancer1 trial

Advanced/Metastatic Solid Tumors1 trial

Radiotherapy1 trial

Bevacizumab1 trial

Second-line Treatment1 trial

Advanced Solid Malignancies1 trial

Cognition1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

Related News