Clinical trials: Non-Small Cell Lung Cancer With HER2- Mutations
Advanced Non-small Cell Lung Cancer, HER2 Mutation
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
- Trial name
- SOHO-02 (NCT06452277)
- Testing
- Sevabertinib, Pembrolizumab, Cisplatin
- Where
- 279 sites in United States, Argentina and 34 more
- Volunteers
- 444 people
- Sponsor
- Bayer
Non-small Cell Lung Cancer
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase…
- Trial name
- NCT02535507
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Tongji University
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Non-Small Cell Lung Cancer With HER2- Mutations
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
- Trial name
- NCT06430437
- Testing
- SHR-A1811, PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult…
- Conditions
- Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression
- Trial name
- NCT07361562
- Testing
- CGT4255
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cogent Biosciences, Inc.
Advanced Solid Tumor, Non Small Cell Lung Cancer
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, HER2 Mutations
- Trial name
- NCT05532696
- Testing
- ABT-101
- Where
- 5 sites in Taiwan
- Volunteers
- 61 people
- Sponsor
- Anbogen Therapeutics, Inc.
Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, RC48, Disitamab Vedotin
- Trial name
- NCT05847764
- Testing
- RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L, RC48+Furmonertinib, 2L+
- Where
- China
- Volunteers
- 95 people
- Sponsor
- Sun Yat-sen University
Lung Cancer
Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression
The goal of this clinical trial is to learn ifDisitamab Vedotin in combination with tislelizumab and bevacizumab can treat in locally advanced or metastatic non-small cell lung cancer patients with HER2…
- Trial name
- NCT06749860
- Testing
- Disitamab Vedotin + tislelizumab + bevacizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
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
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer…
- Trial name
- NCT07195695
- Testing
- Zongertinib, Pembrolizumab, Atezolizumab
- Where
- 202 sites in United States, Argentina and 26 more
- Volunteers
- 400 people
- Sponsor
- Boehringer Ingelheim
Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, ERBB2 Gene Duplication, Disitamab Vedotin
- Trial name
- NCT06185400
- Testing
- Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib), pyrotinib
- Volunteers
- 108 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Adult Solid Neoplasm, Bladder Carcinoma
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that…
- Conditions
- Adult Solid Neoplasm, Bladder Carcinoma, Colon Carcinoma, Estrogen Receptor Negative
- Trial name
- NCT02432963
- Testing
- Laboratory Biomarker Analysis, Modified Vaccinia Virus Ankara Vaccine Expressing p53, Pembrolizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
Lung Cancer
HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598
RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
- Trial name
- NCT00896909
- Testing
- gene expression analysis, mutation analysis, polymerase chain reaction
- Volunteers
- 44 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
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
NSCLC
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant.
- Trial name
- NCT03318939
- Testing
- Poziotinib
- Where
- 63 sites in United States, Belgium and 6 more
- Volunteers
- 648 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Advanced Non-small Cell Lung Cancer, EGFR Mutation
First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation
- Trial name
- NCT05099172
- Testing
- BAY2927088_formulation A, BAY2927088_formulation B_1, BAY2927088_formulation B_2
- Where
- 94 sites in United States, Belgium and 14 more
- Volunteers
- 430 people
- Sponsor
- Bayer
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
- Trial name
- NCT05048797
- Testing
- Trastuzumab Deruxtecan, Cisplatin, Carboplatin
- Where
- 130 sites in United States, Austria and 18 more
- Volunteers
- 454 people
- Sponsor
- AstraZeneca
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive…
- Trial name
- SUMMIT (NCT01953926)
- Testing
- Neratinib, Fulvestrant, Trastuzumab
- Where
- 60 sites in United States, Australia and 11 more
- Volunteers
- 582 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced Non-small Cell Lung Cancer, Cancer
Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human…
- Trial name
- NCT06761976
- Testing
- Sevabertinib
- Sponsor
- Bayer