Mutation in ERBB2
HER2 (ERBB2) activating mutation
- Active trials
- 49
- Recruiting now
- 26
- FDA approvals
- 5
- EU approvals
- 1
- Companies
- 24
Trials that select patients by HER2 (ERBB2) activating mutation or a broader group that includes it, the therapies approved for it, and who is developing what. Seen most often in NSCLC.
Added in v3.0. Matches on this page are included in our accuracy checks (about 9 in 10 correct across all pages) but have had fewer checks than the original pages. Every trial shows the words that matched.
Trials as of 2026-10-27. No new trials, status changes or approvals since 2026-10-20. Earlier weeks. Follow this page. Spot something wrong? Tell us.
Approved therapies
Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.
Results side by side
The pivotal trials behind the approvals below, on one scale. Trials differ in patients, earlier treatment and comparator, so this is a map of the evidence, not a ranking.
| Therapy | Tumour | United States | European Union |
|---|---|---|---|
sevabertinib
|
NSCLC | Approved 2025 accelerated | Not approved |
SOHO-01
single-arm, 70 no prior HER2 drug; 52 after a HER2 ADC Serious side effects 33%Stopped for side effects 4.2%Fatal 0.5% Trial details and side effects
|
|||
trastuzumab deruxtecan
|
NSCLC | Approved 2022 accelerated | Approved 2023 |
In the US approval report
DESTINY-Lung02
single-arm, 52 patients
Trial details and side effects
In the EU approval report
DESTINY-Lung02
single-arm Trial details and side effects
|
|||
zongertinib
|
NSCLC | Approved 2025 accelerated | Not approved |
Beamion LUNG-1
single-arm, 71 after platinum; 34 after platinum and a HER2 ADC Serious side effects 36%Stopped for side effects 6%Fatal 0.6% Trial details and side effects
|
|||
Companion diagnostic tests
Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.
| Test | Sample | For | Tumour | Since |
|---|---|---|---|---|
| Guardant360 CDxGuardant Health | plasma | trastuzumab deruxtecan, zongertinib | NSCLC | 2022 |
| Oncomine Dx Target TestLife Technologies | tissue | trastuzumab deruxtecan, zongertinib, sevabertinibzongertinib and sevabertinib per their FDA approval announcements | NSCLC | 2022 |
Drugs in active trials
Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.
25 of 44 drugs shown
| Drug | Type | Active trials | Furthest phase | Lead sponsors |
|---|---|---|---|---|
| trastuzumab deruxtecan FDA EUHER2 | HER2 ADC | 9 | Phase 3 | AstraZeneca, Daiichi Sankyo, Enliven Therapeutics |
| zongertinib FDAHER2 | HER2 TKI | 6 | Phase 3 | Boehringer Ingelheim |
| sevabertinib FDAHER2 | HER2 TKI | 3 | Phase 3 | Bayer |
| pembrolizumabPD-1 | anti-PD-1 antibody | 7 | Phase 3 | Boehringer Ingelheim, Baili-Bio / SystImmune, Bayer |
| atezolizumabPD-L1 | anti-PD-L1 antibody | 3 | Phase 3 | Boehringer Ingelheim |
| trastuzumab rezetecanHER2 | HER2 ADC | 2 | Phase 3 | Jiangsu Hengrui |
| BL-M07D1HER2 | HER2 ADC | 1 | Phase 3 | Baili-Bio / SystImmune |
| durvalumabPD-L1 | anti-PD-L1 antibody | 1 | Phase 3 | Boehringer Ingelheim |
| nivolumabPD-1 | anti-PD-1 antibody | 1 | Phase 3 | Boehringer Ingelheim |
| YK-209A | Not yet classified | 1 | Phase 3 | Suzhou Puhe Pharmaceutical Technology |
| STX-721 | Not yet classified | 3 | Phase 1/2 | Pierre Fabre Medicament |
| trastuzumabHER2 | anti-HER2 antibody | 3 | Phase 2 | Pfizer |
| disitamab vedotinHER2 | HER2 ADC | 2 | Phase 1/2 | RemeGen |
| fulvestrantER | oestrogen receptor degrader | 2 | Phase 2 | Pfizer |
| neratinibHER2 | HER2 TKI | 2 | Phase 2 | Academic only |
| trastuzumab emtansineHER2 | HER2 ADC | 2 | Phase 2 | Enliven Therapeutics |
| tucatinibHER2 | HER2 TKI | 2 | Phase 2 | Pfizer |
| ABT-101 | Not yet classified | 1 | Phase 1/2 | Anbogen Therapeutics |
| afatinibEGFR/HER2 | EGFR TKI (2nd generation) | 1 | Phase 2 | Academic only |
| BEBT-109 | Not yet classified | 1 | Phase 2 | BeBetter Med |
| bevacizumabVEGF-A | anti-VEGF antibody | 1 | Phase 2 | Academic only |
| BH-30643 | Not yet classified | 1 | Phase 1/2 | BlossomHill Therapeutics |
| cabozantinibMET/VEGFR2 (multi-kinase) | multi-kinase inhibitor | 1 | Phase 2 | Academic only |
| erlotinibEGFR | EGFR TKI (1st generation) | 1 | Phase 2 | Academic only |
| inavolisibPI3Kα | PI3Kα inhibitor | 1 | Phase 2 | Academic only |
| iparomlimab and tuvonralimabPD-1 + CTLA-4 | PD-1/CTLA-4 antibody combination | 1 | Phase 2 | Academic only |
| ipatasertibAKT | AKT inhibitor | 1 | Phase 2 | Academic only |
| JS207PD-1 x VEGF | PD-1/VEGF bispecific antibody | 1 | Phase 2 | Academic only |
| JS212EGFR x HER3 | EGFR-HER3 bispecific ADC | 1 | Phase 2 | Academic only |
| JSKN033 | Not yet classified | 1 | Phase 2 | Jiangsu Alphamab Biopharmaceuticals |
| mobocertinibEGFR exon 20 | EGFR exon 20 insertion TKI | 1 | Phase 1/2 | Takeda |
| olaparibPARP | PARP inhibitor | 1 | Phase 2 | Academic only |
| ORIC-114EGFR/HER2 exon 20 | brain-penetrant EGFR/HER2 inhibitor | 1 | Phase 1/2 | ORIC Pharmaceuticals |
| pertuzumabHER2 | anti-HER2 antibody | 1 | Phase 2 | Academic only |
| pyrotinibHER2 | HER2 TKI | 1 | Phase 1/2 | RemeGen |
| sacituzumab govitecanTROP2 | TROP2 ADC | 1 | Phase 2 | Academic only |
| sunvozertinibEGFR exon 20 | EGFR exon 20 insertion TKI | 1 | Phase 1/2 | Dizal Pharmaceuticals |
| SYS6045 | Not yet classified | 1 | Phase 1/2 | CSPC |
| YH42946 | Not yet classified | 1 | Phase 1/2 | Yuhan |
| CGT4255 | Not yet classified | 1 | Phase 1 | Cogent Biosciences |
| ELVN-002 | Not yet classified | 1 | Phase 1 | Enliven Therapeutics |
| furmonertinibEGFR | EGFR TKI (3rd generation) | 1 | Phase 1 | ArriVent BioPharma |
| KM501 | Not yet classified | 1 | Phase 1 | Xuanzhu Biopharmaceutical |
| NVL-330 | Not yet classified | 1 | Phase 1 | Nuvalent |
Upcoming readouts
Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.
Companies
Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.
- Boehringer Ingelheim 5
- AstraZeneca 3
- Bayer 3
- Daiichi Sankyo 2
- Baili-Bio / SystImmune 1
- Jiangsu Hengrui 1
- Suzhou Puhe Pharmaceutical Technology 1
- BeBetter Med 1
- Jiangsu Alphamab Biopharmaceuticals 1
- Pfizer 1
- Anbogen Therapeutics 1
- BlossomHill Therapeutics 1
- CSPC 1
- Dizal Pharmaceuticals 1
- ORIC Pharmaceuticals 1
Trials
Matched automatically from registry text, so a few trials may only mention HER2 (ERBB2) activating mutation rather than require it. Check the quoted criterion, and the registry entry before relying on a match.
49 of 91 trials shown
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Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
zongertinib FDApembrolizumabatezolizumabdurvalumabnivolumab
HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor recepto…
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
BL-M07D1pembrolizumabpemetrexedcarboplatincisplatin
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
Non-squamous Non-small Cell Lung Cancer
-
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)
sevabertinib FDApembrolizumabcisplatincarboplatinpemetrexed
Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified…
Advanced Non-small Cell Lung Cancer, HER2 Mutation
-
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
trastuzumab rezetecanpemetrexedpaclitaxelcarboplatincisplatin
Subjects with central laboratory- confirmed functional HER2 mutations
Non-Small Cell Lung Cancer With HER2- Mutations
-
Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
zongertinib FDApembrolizumabcisplatincarboplatinpemetrexed
Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
Lung Cancer, Non-squamous, Non-small Cell
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YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
YK-209A tabletpemetrexedcarboplatincisplatin
…ther alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors \…
Status may be outdated, last updated 2023-04-05Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
-
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
trastuzumab deruxtecan FDA EUcisplatincarboplatinpembrolizumabpemetrexed
Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
-
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
Documented HER2 exon 20 insertion mutation.
Non-small Cell Lung Cancer
-
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
Known activating HER2 mutation.
Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
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PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC
iparomlimab and tuvonralimabpemetrexedbevacizumab
and HER2 exon 20 insertions.
Lung Adenocarcinoma
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Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab
zongertinib FDAcisplatincarboplatinpemetrexedpembrolizumab
Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
Lung Cancer, Non-squamous, Non-small Cell
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A Multicenter, Single-Arm, Prospective Phase II Clinical Study of Trastuzumab Rezetecan Combined With Radiotherapy in Patients With HER2-Mutated Oligoprogressive Advanced Non-Small Cell Lung Cancer
Confirmed HER2 mutation (detected by PCR or NGS).
HER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression
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A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
sevabertinib FDA
Documented activating HER2 mutation
Advanced Solid Tumors, HER2 Mutation
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A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer
JSKN033 Injection
…astatic NSCLC who have failed or are intolerant to standard previous treatments, and have HER2 mutation or HER2 expression in tumor tissue.
Non Small Cell Lung Cancer (NSCLC)
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Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
SYS6045
…metastatic solid tumors (excluding breast, colorectal, and NSCLC), with HER2 expressionor HER2 mutation.
Advanced Solid Tumors
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A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
BH-30643carboplatinpemetrexed
Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
NSCLC (Advanced Non-small Cell Lung Cancer)
-
Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations
BEBT-109 Capsulespemetrexedcarboplatincisplatin
Patients may have only EGFR exon 20 insertion mutations or may also have other EGFR or HER2 mutations;
Non Small Cell Lung Cancer
-
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
…ening, histologically confirmed cancers in patients with previously documented activating HER2 mutation (see Appendix A) confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certifi…
Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
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Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer
disitamab vedotincarboplatin
HER2 mutations identified by histological specimens;
Non-small Cell Lung Cancer
-
Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases
trastuzumab deruxtecan FDA EU
Activating HER2-mutation documented by NGS in tissue or plasma (include activating HER2 mutation in exon 19 or 20,…
Non Small Cell Lung Cancer
-
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
YH42946
…ients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)
NSCLC (Non-small Cell Lung Cancer), Solid Tumor
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Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
zongertinib FDA
…ented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
Solid Tumours
-
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
trastuzumab deruxtecan FDA EU
o Has a history of Her2 expression or activating Her2-mutation
Brain Cancer, Glioblastoma, Metastatic Cancer, Leptomeningeal Metastasis
-
Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)
atezolizumabinavolisibipatasertibolaparibsacituzumab govitecantrastuzumabpertuzumab
Arm 6 (Trastuzumab / Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation
Early-stage Breast Cancer
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A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain
…ymal progression in patients with HER2+/mutant lung/esophagogastric/colorectal cancer and HER2 mutant breast cancer
Metastatic Breast Cancer
-
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
STX-721/PFL-721 (Escalated)STX-721/PFL-721 (3 dose levels)STX-721/PFL-721 (RP2D)
Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories.
Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
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A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
trastuzumab deruxtecan FDA EU
…Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
HER2-mutant Non-Small Cell Lung Cancer
-
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
ORIC-114carboplatinpemetrexed
HER2 exon 20 insertion mutation
Solid Tumors
-
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
ABT-101
Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2)
Status may be outdated, last updated 2024-06-24Advanced Solid Tumor, Non Small Cell Lung Cancer, HER2 Mutations
-
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
tucatinibtrastuzumabfulvestrant
Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms
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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)
sevabertinib FDA
Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States …
Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation
-
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
trastuzumab deruxtecan FDA EU
Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772\_A775dup / A775\_G776insYVMA, L755…
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
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Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
trastuzumabtrastuzumab emtansine
HER2 or ERBB2 mutated on tumor genomic sequencing assay (see Section 9.1 for permitted HER2 mutations)
Salivary Gland Cancer, HER2 Gene Mutation
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Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
…d histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.
Non-Small Cell Lung Cancer
-
A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer
A HER2 exon 20 insertion;
Carcinoma, Non-Small-Cell Lung
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Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
Patient's tumor must have activating HER2 mutation, as determined via the MATCH Master Protocol
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
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A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
trastuzumab deruxtecan FDA EU
NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) m…
Recurrent or Metastatic Solid Tumors
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A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
CGT4255
Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression
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A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
NVL-330
Phase 1b: Documented oncogenic HER2 mutation.
Locally Advanced Solid Tumor, Metastatic Solid Tumor
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A Study of KM501 in Patients With Solid Tumors
KM501
Advanced non-small cell lung cancer with a HER2 mutation.
Status may be outdated, last updated 2023-04-07Advanced Solid Tumors
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ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
ELVN-002trastuzumab deruxtecan FDA EUtrastuzumab emtansine
HER2 mutation identified by tissue (fresh or archival) or ctDNA.
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
-
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
…e or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.
Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations
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Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene
neratinibtrastuzumab deruxtecan FDA EU
A known HER2 activating mutation
Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
-
Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
zongertinib FDA
…ll lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.
Neoplasm Metastasis, Non-Small Cell Lung Cancer
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DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
trastuzumab deruxtecan FDA EUpembrolizumab
Pathologically documented, locally advanced/metastatic HER2-mutant NSCLC
Breast Cancer, Non-small Cell Lung Carcinoma
-
Exercise to Improve Neurovascular Function in Breast Cancer Survivors
Trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
Breast Cancer Survivorship
-
Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy
JS207pemetrexedcarboplatincisplatinJS212
…600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mutation, HER-2 mutation, EGFR 20 exon insertion mutation.
Broad match: HER2 (ERBB2) activating mutationNon-squamous Non-small Cell Lung Cancer
-
HTL0039732 in Participants With Advanced Solid Tumours
HTL0039732 Capsulesatezolizumab
MSS CRC with PIK3CA or HER2 mutation/genetic aberration, and/or other driver mutation/genetic aberration as agreed with the Sp…
Broad match: HER2 (ERBB2) activating mutationNeoplasms, Prostatic Neoplasms, Castration-Resistant, Stomach Neoplasms, Esophageal Neoplasms
-
Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
…rcoma viral oncogene homolog B (BRAF) mutation, human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by t…
Broad match: HER2 (ERBB2) activating mutationRecurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7
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Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in PIK3CA-mutated HER2+ Advanced BC (ALPHABET)
trastuzumabalpelisibfulvestrantvinorelbinecapecitabineeribulin
Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in PIK3CA-mutated HER2+ Advanced BC (ALPHABET)
Advanced Breast Cancer
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TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
mobocertinibpemetrexedcisplatincarboplatin
…ther alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors \…
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
-
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
trastuzumab deruxtecan FDA EU
The presence of any activating HER2 mutation is suitable.)of HER2including via Foundation Medicine testing on the LCMC4 LEADER protoco…
Non-Small Cell Lung Cancer, Non-small Cell Lung Cancer Stage II, Non-Small Cell Lung Cancer Stage IIIA, Non-Small Cell Lung Cancer Stage IIIB
-
JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors
JSKN033 Injection
HER2 mutation in patients with NSCLC is also regarded as HER2 expression.
Advanced Solid Tumor
-
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
3.Previously underwent second-generation sequencing testing with evidence of HER2 mutation, otherwise, the patient must provide sufficient tissue samples for second-generation sequ…
Advanced Solid Tumor
-
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
disitamab vedotintislelizumabcarboplatinfurmonertinib
Arm 3: HER2 gene mutations, no other driver gene alterations;
Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, RC48, Disitamab Vedotin
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Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma
Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma
Bile Duct Adenocarcinoma Non-Resectable, HER2 Gene Mutation
-
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Aden…
Solid Tumor
-
ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)
Cohort 1, Cohort 2, and Explanatory Cohort A: HER2 mutated subjects with pre-specified HER2 activating mutation.
HER2 Mutation-Related Tumors, HER2 Amplified Solid Tumors
-
A Study of MRG002 in the Treatment of Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC).
MRG002
Advanced NSCLC patients with HER2 mutation in tumor tissue/blood confirmed by NGS/PCR methods.
Non-small- Cell Lung Cancer (NSCLC)
-
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
trastuzumab deruxtecan FDA EU
Pathologically documented metastatic NSCLC with a known activating HER2 mutation.
Non-Small Cell Lung Cancer
-
Study of Poziotinib in Japanese Patients With NSCLC
Phase 2: Documented EGFR or HER2 exon 20 insertion mutations (including duplication mutations) in NSCLC patients
NSCLC
-
Pyrotinib Plus Thalidomide in Advanced NSCLC Patients Harboring HER2 Exon 20 Insertions
HER2 exon 20 insertions confirmed by next generation sequencing or polymerase chain reaction (if blood samples ar…
Non-small-cell Lung Cancer
-
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
poziotinibLoperamide
Patients with BC must have a HER2 activating mutation determined by next-generation sequencing (NGS) performed on either tumor or plasma sample…
Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
-
Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions
EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
NSCLC, Stage IV, NSCLC Stage IIIB, NSCLC, Stage IIIC, NSCLC, Recurrent
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Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation
Histologically or cytologic confirmed EGFR or HER2 Exon 20 Insertion Mutation positive advanced Non-small cell lung cancer who failed prior therapies.
Non Small Cell Lung Cancer
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Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Cohort 2: Documented HER2 exon 20 insertion mutation (including duplication mutations)
NSCLC
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Her2-positive Lung Cancer Treated With Dedicated Drug
pertuzumabtrastuzumabdocetaxel
…ith Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel
Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Stage III, HER2 Gene Mutation
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DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
trastuzumab deruxtecan FDA EU
For Cohort 2 only: Participant has any known documented activating HER2 mutation from an archival tumor tissue sample analyzed by CLIA laboratory or equivalent.
Non-Small Cell Lung Cancer
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Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status
HER2 mutation confirmed by CLIA testing of tumor, and with or without prior treatment with cetuximab or…
Metastatic Colorectal Cancer
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Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC
A Phase II Study of Poziotinib in EGFR or HER2 Mutant Advanced Solid Tumors
EGFR Exon 20 Mutation, ERBB2 Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7
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Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
NSCLC
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An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation
afatinibpaclitaxel
… locally advanced or metastatic cancers harboring either an activating EGFR mutation or a HER2 mutation or a HER3 mutation
Cancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation
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A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
Confirmed HER2 mutation by Central Laboratory。
Non Small Cell Lung
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Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity
Patients must have tumours harbouring a sensitising EGFR mutation or HER2 mutation in at least one biopsy at recurrence, or region of the primary sample.
Non-small Cell Lung Cancer
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Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772\_A775dup), insGSP (…
Solid Tumor Cancers, Lung Cancer, Bladder Cancer, Urinary Tract Cancers
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Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)
Patients with HER2 mutation by sequencing
HER2 Gene Mutation, Adenocarcinoma Lung Stage IV
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Afatinib in NSCLC With HER2 Mutation
afatinibpaclitaxel
Tumor tissue with HER2 mutations as confirmed by AmoyDx® HER2 Mutation Detection Kit
Carcinoma, Non-Small-Cell Lung
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Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer
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A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer
Ibrutinib
For HER2 mutant cohort, patients must have: a) Documented EGFR mutation by CLIA-certified test b)Document…
Lung Cancer
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AUY922 in Patient With Stage IV NSCLC
AUY922
HER2 mutation in exon 20
Non-small Cell Lung Cancer (NSCLC)
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Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
neratinibtemsirolimus
Documented somatic ErbB2 (HER2) activating mutation.
HER2-mutant Non-Small Cell Lung Cancer
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Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
neratinibfulvestranttrastuzumab
for Registration (for patients with HER2 mutation identified at an outside CLIA certified location):
Breast Neoplasms
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Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis
Trotabresibvinorelbine
Alternatively, circulating tumor DNA testing positive for HER2 mutation is accepted for eligibility
Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Neoplasm in the Leptomeninges
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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)
sunvozertinibmidazolam
…ocktail Probes Representative for CYP3A4, P-gp, BCRP and OATP1B1 in Patients with EGFR or HER2 Mutant Advanced Non-small Cell Lung Cancer (WU-KONG19)
Non-small Cell Lung Cancer
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Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Patients with EGFR or HER2 mutations;
Non-Small-Cell Lung Cancer
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Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2
HLX22
HER2 mutation of at least 3+ (+++) or
Solid Tumor
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A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
BDTX-189
EGFR or HER2 exon 20 insertion mutation(s)
Solid Tumor
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A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
Cohort 12 advanced solid tumor cancers with HER2 activating mutation.
Breast Neoplasms, Gastric Neoplasm, Solid Tumors
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Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Patients with documented HER2 mutated NSCLC whose disease progressed on prior therapy;
Breast Cancer, Gastric Cancer, Solid Tumors, NSCLC
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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
trastuzumab deruxtecan FDA EU
Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard tr…
Advanced Solid Tumors
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A Study of FWD1509 in Adults With Non-Small Cell Lung Cancer
FWD1509 MsOH
Phase 1 Dose-escalation part: EGFR and HER2 mutations (including but not limited toL858R, exon 19 deletion, T790M, ex20ins, 21exon, G719X, S768…
Broad match: HER2 (ERBB2) activating mutationCarcinoma, Non-Small-Cell Lung
No trials match these filters.