EGFR TKI (3rd generation) · small molecule

aumolertinib

22 active trials across 7 of our biomarkers, targeting EGFR. Not approved for any biomarker on marked.bio yet.

Also known as almonertinib, HS-10296, Ameile, Aumseqa.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Therapy	Biomarker	Tumour	United States	European Union
aumolertinib EU (EMA), 2026 first line, advanced, EGFR exon 19 deletions or exon 21 L858R MA 12/02/2026 (CHMP opinion 11/12/2025). EMA medicines data (updated 05/10/2026) show status 'Revoked' dated 25/09/2026, but the EPAR page (last updated 27/02/2026) still says 'Authorised'. Status set to withdrawn based on the newer EMA data; reason not published. Also authorised for T790M (not tracked here). Source Aumseqa	EGFR exon 19 deletion / L858R	NSCLC	Not approved	Withdrawn approved 2026

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
EGFR exon 19 deletion / L858R	22	53	Phase 3
ALK fusion	1	1	Phase 2
BRAF V600E	1	1	Phase 2
BRCA1/2 mutation	1	1	Phase 2
EGFR exon 20 insertion	1	2	Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-)	1	1	Phase 2
ROS1 fusion	1	1	Phase 2

Trials

22 of 54 trials shown

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

Active, not recruiting Phase 3 Jiangsu Hengrui Started 2025Primary completion 2032-11 NCT07183189

SHR-A2009aumolertinib

…lly confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

Recruiting Phase 3 Shanghai Cancer Hospital Started 2023Primary completion 2027-12 NCT05800223

aumolertinib

5. epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation (alone or in combination with other EGFR mutatio…

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-04-05Non-small Cell Lung Cancer Metastatic
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

Recruiting Phase 3 Sun Yat-sen University Started 2023Primary completion 2028-12 NCT05768490

aumolertinib

EGFR sensitivity mutation (exon19del or exon21 L858R);

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-03-14Brain Metastases, Radiotherapy, EGFR Activating Mutation
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance

Recruiting Phase 3 Qianfoshan Hospital Started 2023Primary completion 2026-09 NCT06043973

aumolertinibanlotinib

Patients with EGFR mutation and TP53 mutation advanced Non-squamous NSCLC.

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-09-21Advanced Non-small Cell Lung Cancer
MDT-bridged Radical Therapy After Aumolertinib With MRD-guided Maintenance in EGFRm+ Unresectable Stage III NSCLC (APPROACH)

Active, not recruiting Phase 3 Guangdong Association of Clinical Trials Started 2022Primary completion 2026-12 NCT04841811

aumolertinib

…es effusions, and pericardial effusions are confirmed to be EGFR sensitive mutations (ie, exon 19 deletion or L858R, alone or coexisting, Or with other EGFR mutations, but patients with EGFR20 exo…

EGFR exon 19 deletion / L858RLung Cancer
Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations

Active, not recruiting Phase 3 Hansoh Pharma Started 2021Primary completion 2024-06 NCT04923906

aumolertinib

…arbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations assessed by central tes…

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations

Active, not recruiting Phase 3 Hansoh Pharma Started 2021Primary completion 2024-07 NCT04687241

aumolertinib

…bors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

Recruiting Phase 3 Hansoh Pharma Started 2021Primary completion 2024-07 NCT04951635

aumolertinib

…rs one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19Del, L858R), either alone or in combination with other EGFR mutations including T790M, assess…

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2022-06-16Non-small Cell Lung Cancer
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 Phase 3 Chinese Academy of Medical Sciences Started 2021Primary completion 2026-05 NCT04762459

aumolertinibpemetrexedcisplatin

…ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2022-02-24Non-small Cell Lung Carcinoma
Aumolertinib Combined With Phased Chemotherapy for EGFR L858R Lung Adenocarcinoma

Recruiting Phase 2 Taipei Medical University Hospital Started 2026Primary completion 2028-12 NCT07624487

aumolertinibpemetrexedcarboplatin

Documentation of an EGFR L858R mutation is mandatory.

EGFR exon 19 deletion / L858RLung Adenocarcinoma Metastatic
First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations

Not yet recruiting Phase 2 Yongsheng Wang Started 2026Primary completion 2029-03 NCT07699952

aumolertinibtrastuzumab rezetecan

Confirmed EGFR mutations via genetic testing, including Exon 19 deletion or L858R point mutation;

EGFR exon 19 deletion / L858RHER2-low / ultralow (IHC 1+ or 2+/ISH-)Lung Cancer (NSCLC), EGFR Activating Mutation, HER2
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

Not yet recruiting Phase 2 Peking Union Medical College Hospital Started 2024Primary completion 2027-01 NCT06752408

aumolertinibosimertinib FDA EU

… effusion, ascites, cerebrospinal fluid) with at least one sensitizing mutation (L858R or 19Del).

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Active, not recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024Primary completion 2026-01 NCT06300424

aumolertinibcarboplatinnab-paclitaxel

6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q

EGFR exon 19 deletion / L858REGFR exon 20 insertionNon Small Cell Lung Cancer, EGFR Gene Mutation
Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer.

Not yet recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2024Primary completion 2027-12 NCT06452433

glumetinibosimertinib FDA EUaumolertinibfurmonertinib

Patients with EGFR mutations known to be associated with drug sensitivity (i.e., exon 19 deletion or L858R mutation).

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-06-11Non-small Cell Lung Cancer
Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

Not yet recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2023Primary completion 2025-03 NCT05778149

aumolertinibanlotinib

Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-03-21Aumolertinib, Anlotinib, TP53, NSCLC
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 Phase 1/2 Jiangsu Hengrui Started 2022Primary completion 2027-07 NCT05503888

aumolertinib

…Innovative Drugs in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer With EGFR Mutation

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2022-08-17Relapsed or Advanced Non-small Cell Lung Cancer
Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer

Active, not recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2021Primary completion 2022-12 NCT04685070

aumolertinib

Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lung Cancer

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-08-14Non-small Cell Lung Cancer Stage III
PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor
A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC

Recruiting Phase 1 Hansoh Pharma Started 2025Primary completion 2025-10 NCT06926413

aumolertinibmidazolam

…nti-tumor systemic therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R, single mutation or combined with other EGFR mutations are both acceptable).

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer

Recruiting Phase 1 Hansoh Pharma Started 2024Primary completion 2025-08 NCT07130916

aumolertinib

…nti-tumor systemic therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
MRD-Guided Aumolertinib-Based Adjuvant Therapy for Resected EGFR-Mutant NSCLC

Not yet recruiting No phase Peking University People's Hospital Started 2026Primary completion 2030-10 NCT07873086

aumolertinibpemetrexedcarboplatin

EGFR exon 19 deletion and/or exon 21 L858R mutation detected by histological or cytological testing.

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation

Recruiting No phase Kunming Medical University Started 2023Primary completion 2026-10 NCT06102928

anlotinibaumolertinib

… IIIB, IIIC, or IV) confirmed by histology or cytology, with the presence of EGFR 21 exon L858R mutation in the driving gene

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-10-26Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study

Unknown status Phase 4 Tian Xie Started 2020 NCT04401059

Elemene plus first or third generation EGFR-TKIsgefitinib FDA EUerlotinib FDA EUicotinibosimertinib FDA EUaumolertinibfurmonertinib

Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene), plan to receive First-generation EGFR-TKIs (Gefit…

EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung Cancer, Adenocarcinoma
Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer

Unknown status Phase 2/3 Laibin People's Hospital Started 2023 NCT05994339

aumolertinib

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

EGFR exon 19 deletion / L858RLung Cancer Stage III
Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

Terminated Phase 3 EQRx International Started 2022 NCT05493501

aumolertinibosimertinib FDA EUpemetrexedcisplatincarboplatinpaclitaxelnab-paclitaxelgemcitabine

…rbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity-ex19del or L858R-either alone or in combination with other EGFR mutations (eg, G719X, exon 20 ins…

EGFR exon 19 deletion / L858RNSCLC
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 Phase 3 Hansoh Pharma Started 2021 NCT04951648

aumolertinibchemotherapy

The tumor harbors uncommon EGFR mutations (one of the following EGFR mutation: L861Q, G719X or S768I), assessed by Xiamen AmoyDx EG…

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
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 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020 NCT04500704

aumolertinibcarboplatinpemetrexed

…ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), in combination with non-EGFR driver genes mutations assessed by central testing …

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

Unknown status Phase 3 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020 NCT04500717

aumolertinibcarboplatinpemetrexed

…ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), in combination with tumor suppressor genes mutations assessed by central testing…

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients

Unknown status Phase 3 Hansoh Pharma Started 2019 NCT03849768

aumolertinibgefitinib FDA EU

…ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing u…

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).

Withdrawn Phase 2 Sun Yat-sen University Started 2024 NCT06227897

aumolertinib

EGFR activating mutation in exon 19 or 21.

EGFR exon 19 deletion / L858RLung Cancer
Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer

Unknown status Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2024 NCT06463171

aumolertinib

…he First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations

EGFR exon 19 deletion / L858RLung Cancer Non-small Cell Stage IV
Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity.

Unknown status Phase 2 The First Affiliated Hospital of Guangzhou Medical University Started 2023 NCT05946460

aumolertinib

Presence of at least one resectable malignant EGFR-mutant pulmonary ground-glass nodule diagnosed by AI (CTR ≤ 0.5, EGFR mutation prediction value …

EGFR exon 19 deletion / L858RLung Cancer
Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns

Unknown status Phase 2 Baohui Han Started 2022 NCT04922138

aumolertinib

…ours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.

EGFR exon 19 deletion / L858RLung Cancer
Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer

Unknown status Phase 2 Qianfoshan Hospital Started 2022 NCT04755738

aumolertinib

EGFR Exon 19del or Exon 21 L858R mutations;

EGFR exon 19 deletion / L858RAdvanced Non Small Cell Lung Cancer
Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs

Unknown status Phase 2 Shanghai Cancer Hospital Started 2022 NCT04519983

aumolertinib

Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs

EGFR exon 19 deletion / L858RLung Cancer Stage IV
Envafolimab Immunotherapy After ctDNA EGFR Clearance by Treatment With Almonertinib in EGFR-Mutant, PD-LI Positive NSCLC

Unknown status Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2022 NCT05534113

aumolertinib

…ood samples were confirmed to contain EGFR-sensitive mutations by ctDNA testing(including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations.Patients with EGFR20 exon inser…

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

Unknown status Phase 2 West China Hospital Started 2022 NCT05662813

aumolertinib

…r tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations).

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
Almonertinib Combined With Cerebral Radiation Treat Brain Metastases From EGFR Positive NSCLC

Unknown status Phase 2 Chongqing University Cancer Hospital Started 2021 NCT04905550

aumolertinib

Confirmed pathology of EGFR mutation positive（exon 19 deletion, L858R, T790M）NSCLC with brain metastases on enhanced MRI.

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer (NSCLC)
Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases

Unknown status Phase 2 Zhejiang Cancer Hospital Started 2021 NCT04808752

aumolertinib

…r tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations).

EGFR exon 19 deletion / L858RLung Cancer
Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

Unknown status Phase 2 Fujian Cancer Hospital Started 2021 NCT04354961

aumolertinib

Aumolertinib as First-line Treatment in EGFR-Mutant Pulmonary Adenosquamous Carcinoma: A Multicenter, Single-Arm, Prospective Study (ARISE)

EGFR exon 19 deletion / L858RPulmonary Adenosquamous Carcinoma
Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment

Unknown status Phase 2 Shanghai Chest Hospital Started 2021 NCT04882345

aumolertinib

…ally advanced or metastatic NSCLC are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations).

EGFR exon 19 deletion / L858RLung Cancer, EGFR Gene Mutation
Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

Unknown status Phase 2 Yuan Chen Started 2021 NCT04952168

aumolertinib

Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).

EGFR exon 19 deletion / L858RNSCLC, Stage III
the Efficacy and Safety of Anlotinib Combined With Almonertinib in the First-line Treatment of Patients With Brain Metastases From EGFR Mutation-positive Non-small Cell Lung Cancer

Unknown status Phase 2 Li-kun Chen Started 2021 NCT04978753

anlotinibaumolertinib

…ined With Almonertinib in the First-line Treatment of Patients With Brain Metastases From EGFR Mutation-positive Non-small Cell Lung Cancer

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, Brain Metastases
Almonertinib With Chemotherapy in mEGFR NSCLC

Unknown status Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2020 NCT04646824

aumolertinibpemetrexedcisplatin

… with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EG…

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer Metastatic
A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

Unknown status Phase 2 First People's Hospital of Hangzhou Started 2020 NCT04636593

aumolertinib

Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating Mutation
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 Phase 2 First People's Hospital of Hangzhou Started 2020 NCT04643847

aumolertinib

EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation).

EGFR exon 19 deletion / L858REGFR Positive Non-small Cell Lung Cancer, Brain Metastases
Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC

Unknown status Phase 2 The First Affiliated Hospital of Guangzhou Medical University Started 2020 NCT04455594

aumolertiniberlotinib FDA EUcisplatincarboplatinpemetrexed

… samples are confirmed as EGFR sensitive mutations by central laboratory tests (including Ex19del or L858R, both alone or with other EGFR mutations).

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer Stage IIIA
Almonertinib as Upfront Treatment for Uncommon EGFR Mutation Harboring Non-Small-Cell Lung Cancer Patients: A Multicenter, Open-Label, Phase II Trial

Unknown status Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2020 NCT04553887

aumolertinib

Cohort A: Patients with EGFR exon 20 insertion, failure of first-line standard chemotherapy, or intolerance to chemotherapy Cohort B: Pa…

EGFR exon 20 insertionNon Small Cell Lung Cancer
A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC

Unknown status Phase 2 Jiangsu Hengrui Started 2019 NCT03904823

famitinib poaumolertinib

A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC

EGFR exon 19 deletion / L858REGFR-mutant Non-Small Cell Lung Cancer
Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

Unknown status Phase 1 Guangzhou Institute of Respiratory Disease Started 2022 NCT05826483

aumolertinib

NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing.

EGFR exon 19 deletion / L858RMalignant Tumor of Lung, Poor Performance Status
Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC

Unknown status Phase 1 Hansoh Pharma Started 2022 NCT05430386

aumolertinib

…h disease progression during or after the last treatment: EGFR sensitive mutation (either exon 19 deletion or L858R mutation)

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
A Study of Gentuximab in Combination With Almonertinib in EGFR Mutation-positive Metastatic NSCLC

Unknown status Phase 1 Changchun GeneScience Pharmaceutical Started 2021 NCT05223595

aumolertinib

…h erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].

EGFR exon 19 deletion / L858RMetastatic Non-Small Cell Lung Cancer
A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)

Unknown status No phase Henan Cancer Hospital Started 2021 NCT04778800

aumolertinibLM-first line treatmentLM-second line treatment

Tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;

EGFR exon 19 deletion / L858RNSCLC, Brain Metastases, Leptomeningeal Metastasis
Almonertinib With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis

Unknown status No phase Second Affiliated Hospital of Nanchang University Started 2021 NCT04944069

aumolertinibbevacizumab

Tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R).

EGFR exon 19 deletion / L858RNSCLC, Leptomeningeal Metastasis, EGFR Activating Mutation

Approvals and pivotal results

Biomarkers

Sponsors

Trials