Clinical trials: HER2-mutant Non-Small Cell Lung Cancer
Non Small Cell Lung Cancer
Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases
'1. Objective Primary objective Median Intracranial Progression-free survival(icPFS) as defined by RANO(Response Assessment in Neuro-Oncology) criteria Secondary objective Progression free survival(PFS) as defined by RECIST 1.1…
- Trial name
- ELPIS (NCT06250777)
- Testing
- Trastuzumab deruxtecan
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- Yonsei University
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Non-Small Cell Lung Cancer, Sarcoma
Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands…
- Conditions
- Non-Small Cell Lung Cancer, Sarcoma, Head &Amp; Neck Cancer, Colorectal Carcinoma
- Trial name
- AcSé HER2 (NCT07192068)
- Testing
- Zanidatamab
- Where
- 4 sites in France
- Volunteers
- 105 people
- Sponsor
- UNICANCER
HER2-mutant Non-Small Cell Lung Cancer
Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung…
- Trial name
- NCT01827267
- Testing
- neratinib, temsirolimus
- Where
- 21 sites in United States, France
- Volunteers
- 62 people
- Sponsor
- Puma Biotechnology, Inc.
Non-small Cell Lung Cancer
Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
Trastuzumab deruxtecan (T-DXd) is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of T-DXd used in Chinese lung cancer patients with HER2…
- Trial name
- RERUN (NCT06809764)
- Testing
- No drug
- Where
- 36 sites in China
- Volunteers
- 150 people
- Sponsor
- Daiichi Sankyo
HER2-mutant Advanced Non-Small Cell Lung Cancer
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
This is a single-center, observational, bidirectional cohort study evaluating the real-world effectiveness, safety, and quality of life associated with sevabertinib in Chinese adults with HER2-mutant advanced non-small cell lung…
- Trial name
- NCT07880353
- Testing
- Sevabertinib
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Ruijin Hospital
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses.
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
- Trial name
- HER2 (NCT05650879)
- Testing
- ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 198 people
- Sponsor
- Enliven Therapeutics
Non-small Cell Lung Cancer
Assessing the Effect of DZD9008 on the Pharmacokinetics of the Cocktail Probes Representative for CYP3A4, P-gp, BCRP and OATP1B1 in Patients with EGFR or HER2 Mutant Advanced Non-small Cell Lung Cancer (WU-KONG19)
This study will treat patients with advanced NSCLC who have progressed following prior therapy in order to assess the effect of DZD9008 on exposure of midazolam, digoxin and rosuvastatin, through multiple PK parameters, when…
- Trial name
- NCT05926180
- Testing
- DZD9008 and Probe drugs (midazolam, digoxin, rosuvastatin)
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Dizal Pharmaceuticals
Non-squamous Non-small Cell Lung Cancer
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous…
- Trial name
- NCT07178795
- Testing
- BL-M07D1, Pembrolizumab, Pemetrexed
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Lung Cancer, Non-small Cell
Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment
A prospective, single center, single arm, phase II clinical trial of Pyrotinib combined with pemetrexed plus carboplatin in the first-line treatment of patients with HER2 mutant or amplified recurrent / metastatic non-small cell…
- Trial name
- NCT04706949
- Testing
- Pyrotinib combined with pemetrexed plus carboplatin
- Where
- China
- Volunteers
- 26 people
- Sponsor
- Fudan University
HER2 Mutant Non-small Cell Lung Cancer
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
At present, the main characteristics of the enrolled population in the clinical study of HER2-mutated non-small cell lung cancer are the YVMA mutation type.
- Trial name
- NCT05411276
- Testing
- Pyrotinib maleate
- Volunteers
- 15 people
- Sponsor
- Beijing Chest Hospital
HER2-mutant Non-Small Cell Lung Cancer
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
- Trial name
- DL-05 (NCT05246514)
- Testing
- Trastuzumab deruxtecan
- Where
- 28 sites in China
- Volunteers
- 72 people
- Sponsor
- AstraZeneca
Non-small Cell Lung Cancer
Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer
This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Envafolimab injection (PD-L1) combined with Disitamab Vedotin (HER2 ADC) and Carboplatin for resectable, HER2-Mutant…
- Trial name
- neovision (NCT06734182)
- Testing
- Envafolimab injections+intravenous Disitamab Vedotin+carboplatin
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Guangdong Provincial People's Hospital
Non-small Cell Lung Cancer
Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung Cancer
This is a Phase 1, open-label study to evaluate the safety and the efficacy of inetetamab in combination with pyrotinib in patients in HER2 mutant or amplified patients with advanced non-small cell lung cancer
- Trial name
- NCT05016544
- Testing
- inetetamab, Pytotinib
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-sen University
Non-small Cell Lung Cancer
A Study of BL-M07D1 in Patients With HER2-Overexpressing or HER2-Mutant Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.
- Trial name
- NCT06114511
- Testing
- BL-M07D1
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
EGFR Exon 20 Mutation, ERBB2 Gene Mutation
Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC
This phase II trial studies how well poziotinib works in treating patients with non-small lung cancer with an EGFR or HER2 exon 20 mutation that is stage IV or has come back (recurrent).
- Conditions
- EGFR Exon 20 Mutation, ERBB2 Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7
- Trial name
- NCT03066206
- Testing
- Poziotinib
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- M.D. Anderson Cancer Center