almonertinib

Phase 3Small molecule

Jiangsu Hansoh Pharmaceutical Co., Ltd.

almonertinib is one of 236 small molecule programs targeting Leptomeningeal Metastasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

235

Competitors

Pipeline

Status by Indication[3][1]

Indication

Leptomeningeal MetastasisActive, not recruiting

Lung Cancer (NSCLC)Not yet recruiting

ImmunotherapyRecruiting

Brain MetastasesRecruiting

First-Line TreatmentRecruiting

Rare TumorRecruiting

ResectableRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Non-Small Cell Lung CarcinomaEnrolling by invitation

Patients With Advanced Solid TumorsRecruiting

Leptomeningeal MetastasisPreclinical

Active, not recruiting

Lung Cancer (NSCLC)Phase 2

Not yet recruiting

ImmunotherapyPhase 2

Recruiting

Brain MetastasesPhase 3

Recruiting

First-Line TreatmentPhase 3

Recruiting

Rare TumorPhase 2

Recruiting

ResectablePhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CarcinomaPhase 3

Enrolling by invitation

Patients With Advanced Solid TumorsPhase 2

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Cabometyx

Bristol-Myers Squibb

Phase 3

9 2

Navmi

SSummit Therapeutics

Phase 3

7 3

almonertinib

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

5 4

Divarasib

Roche

Phase 3

7 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 9

Vibramycin

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

Treatment

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Induction Therapy

NCT04841811

Q1 2027

Phase 3Recruiting

Non-Small Cell Lung Cancer

NCT04951635

Phase 1/2Recruiting

Patients With Advanced Solid Tumors

NCT06947811

Q2 2027

Phase 3Recruiting

First-Line Treatment

NCT06043973

Q3 2027

Phase 1/2Not yet recruiting

Non-Small Cell Lung Cancer

NCT05503888

Phase 2Recruiting

Immunotherapy

NCT06300424

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

Recruiting· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 3·NCT04951635·150 enrolled

Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT06463171·60 enrolled

Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer

Not yet recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 1/2·NCT05503888·160 enrolled

Show 2 more trials

Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations

Active, not recruiting· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 3·NCT04687241·192 enrolled

Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

Recruiting·SShanghai Cancer Hospital, China·Phase 3·NCT05800223·300 enrolled

Lung Cancer4 trials

Almonertinib/Pemetrexed/Carboplatin in EGFR T790M+ Advanced Lung Cancer

Unknown status·FFudan University·Phase 2·NCT04592666·226 enrolled

A Phase II Trial of Upfront Radiotherapy Plus Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Brain Metastases

Unknown status·FFirst People's Hospital of Hangzhou·Phase 2·NCT04643847·47 enrolled

Almonertinib as Upfront Treatment for Uncommon EGFR Mutation Harboring Non-Small-Cell Lung Cancer Patients: A Multicenter, Open-Label, Phase II Trial

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT04553887·53 enrolled

Show 1 more trial

Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer

Unknown status·—·Phase 2/3·NCT05994339·40 enrolled

First-line Treatment4 trials

Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

Unknown status·GGuangzhou Institute of Respiratory Disease·Phase 1·NCT05826483·20 enrolled

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

Unknown status·—·Phase 3·NCT04500717·460 enrolled

Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases

Active, not recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT04808752·63 enrolled

Show 1 more trial

Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance

Recruiting·QQianfoshan Hospital·Phase 3·NCT06043973·98 enrolled

Brain Metastases3 trials

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

Almonertinib Combined With Cerebral Radiation Treat Brain Metastases From EGFR Positive NSCLC

Unknown status·—·Phase 2·NCT04905550·50 enrolled

Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

Recruiting·SSun Yat-sen University·Phase 3·NCT05768490·232 enrolled

Advanced NSCLC2 trials

Almonertinib for Advanced NSCLC Patients With Rare Mutations in EGFR

Unknown status·SSun Yat-sen University·Phase 2·NCT04785742·40 enrolled

Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment

Unknown status·SShanghai Chest Hospital·Phase 2·NCT04882345·40 enrolled

14 more indications

Locally Advanced or Metastatic NSCLC2 trials

A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation

Unknown status· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 3·NCT04951648·220 enrolled

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Non-EGFR Driver Gene Mutant, Locally Advanced or Metastatic NSCLC

Unknown status·—·Phase 3·NCT04500704·166 enrolled

Leptomeningeal Metastasis2 trials

A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)

Unknown status·HHenan Cancer Hospital·N/A·NCT04778800·60 enrolled

Almonertinib With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis

Unknown status·SSecond Affiliated Hospital of Nanchang University·N/A·NCT04944069·69 enrolled

Induction Therapy1 trial

MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.

Recruiting·GGuangdong Association of Clinical Trials·Phase 3·NCT04841811·192 enrolled

Immunotherapy1 trial

Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT06300424·32 enrolled

Concurrent Chemoradiotherapy1 trial

Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

Unknown status·YYuan Chen·Phase 2·NCT04952168·26 enrolled

First Line Therapy1 trial

Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

Unknown status·WWest China Hospital·Phase 2·NCT05662813·55 enrolled

Resectable1 trial

A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC

Recruiting·SSichuan University·Phase 2·NCT06951464·40 enrolled

Patients With Advanced Solid Tumors1 trial

A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations

Recruiting·SSun Yat-sen University·Phase 1/2·NCT06947811·71 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Adjuvant Treatment1 trial

Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC

Unknown status·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT04455594·168 enrolled

Non-Small Cell Lung Carcinoma1 trial

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

Enrolling by invitation·CChinese Academy of Medical Sciences·Phase 3·NCT04762459·606 enrolled

Radiotherapy1 trial

A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

Unknown status·FFirst People's Hospital of Hangzhou·Phase 2·NCT04636593·43 enrolled

Squamous Cell Carcinoma1 trial

Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

Unknown status·FFujian Cancer Hospital·Phase 2·NCT04354961·13 enrolled

Lung Cancer (NSCLC)1 trial

First-line Therapy With EGFR-TKI Combined With Trastuzumab Rezetecan for Advanced NSCLC Harboring EGFR Mutations Concomitant With HER2 Alterations

Not yet recruiting·YYongsheng Wang·Phase 2·NCT07699952·35 enrolled

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for almonertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — almonertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for almonertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Jiangsu Hansoh Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Jiangsu Hansoh Pharmaceutical Co., Ltd.

almonertinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Lung Cancer4 trials

First-line Treatment4 trials

Brain Metastases3 trials

Advanced NSCLC2 trials

Locally Advanced or Metastatic NSCLC2 trials

Leptomeningeal Metastasis2 trials

Induction Therapy1 trial

Immunotherapy1 trial

Concurrent Chemoradiotherapy1 trial

First Line Therapy1 trial

Resectable1 trial

Patients With Advanced Solid Tumors1 trial

Rare Tumor1 trial

Adjuvant Treatment1 trial

Non-Small Cell Lung Carcinoma1 trial

Radiotherapy1 trial

Squamous Cell Carcinoma1 trial

Lung Cancer (NSCLC)1 trial

References

Drug Info

Quick Facts

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