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. .

Active trials by phase
Phase 1: 9 active trials19Phase 1/2: 11 active trials1/211Phase 2: 21 active trials221Phase 3: 7 active trials37N/A: 1 active trialsNo phase1
Trials started per year (2026 so far)
2010: 0 trials started20102011: 0 trials started2012: 1 trials started2013: 2 trials started2014: 1 trials started2015: 5 trials started20152016: 6 trials started2017: 3 trials started2018: 3 trials started2019: 8 trials started2020: 7 trials started20202021: 8 trials started2022: 6 trials started2023: 9 trials started2024: 12 trials started122025: 7 trials started2026: 3 trials started32026

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.

Response rates Share of patients whose tumours shrank by at least 30%, with 95% confidence interval where reported.
NSCLC
zongertinib Beamion LUNG-1, no prior HER2 drug 75%
sevabertinib SOHO-01, no prior HER2 drug 71%
trastuzumab deruxtecan DESTINY-Lung02 58%
zongertinib Beamion LUNG-1, after a HER2 ADC 44%
sevabertinib SOHO-01, after a HER2 ADC 38%
TherapyTumourUnited StatesEuropean Union
sevabertinib
FDA, 2025
locally advanced or metastatic non-squamous, HER2 TKD activating mutation, after prior systemic therapy FDA accelerated approval 19/11/2025; companion test Oncomine Dx Target Test. Source
FDA, 2026
first line, locally advanced or metastatic non-squamous, HER2 TKD activating mutation FDA accelerated approval 09/09/2026 (expands the indication to untreated patients). Source
Hyrnuosevabertinib page
NSCLC Approved 2025 accelerated Not approved

SOHO-01 single-arm, 70 no prior HER2 drug; 52 after a HER2 ADC
Response 71% (no prior HER2 drug); 38% (after a HER2 ADC) (59-82; 25-53)Lasting 9.2 months (no prior HER2 drug); 7.0 months (after a HER2 ADC)

Serious side effects 33%Stopped for side effects 4.2%Fatal 0.5%

Trial details and side effects
Patients
HER2 TKD-mutant non-squamous NSCLC after systemic therapy (NCT05099172)
Most common side effects
diarrhoea 90%, rash 76%, stomatitis 37%, paronychia 36%, nausea 22% (191 patients)
Notes
FDA approval summary (2025). Warnings include diarrhoea, liver toxicity and interstitial lung disease. Side effects: Hyrnuo US label, section 6 (HER2-mutant NSCLC).
Source
FDA approval summary
trastuzumab deruxtecan
FDA, 2022
unresectable or metastatic, activating HER2 mutation, after prior systemic therapy FDA accelerated approval 11/08/2022 (5.4 mg/kg). Source
EU (EMA), 2023
advanced, activating HER2 (ERBB2) mutation, needing systemic therapy after platinum chemotherapy with or without immunotherapy EU approval 23/10/2023 (company announcement). Source
Enhertutrastuzumab deruxtecan page
NSCLC Approved 2022 accelerated Approved 2023

In the US approval report

DESTINY-Lung02 single-arm, 52 patients
Response 58% (43-71)Lasting 8.7 months

Trial details and side effects
Patients
HER2-mutant NSCLC after systemic therapy (NCT04644237)
Most common side effects
nausea, fatigue, constipation, decreased appetite, vomiting, alopecia, low blood counts, raised liver enzymes
Notes
FDA approval as reported by ASCO Post (2022). Randomised dose-optimisation trial; figures are for the approved 5.4 mg/kg arm. Interstitial lung disease is a boxed warning.
Source
US approval report

In the EU approval report

DESTINY-Lung02 single-arm
Response 49% (39-59)Lasting 16.8 months

Trial details and side effects
Patients
HER2-mutant NSCLC after systemic therapy (NCT04644237)
Most common side effects
nausea, fatigue, constipation, decreased appetite, vomiting, alopecia, low blood counts, raised liver enzymes
Notes
Later DESTINY-Lung02 analysis at 5.4 mg/kg, as reported by the company at EU approval. Side effects from the US approval.
Source
EU approval report
zongertinib
FDA, 2025
unresectable or metastatic non-squamous, HER2 TKD activating mutation, after prior systemic therapy FDA accelerated approval 08/08/2025; companion test Oncomine Dx Target Test. Source
FDA, 2026
first line, unresectable or metastatic non-squamous, HER2 TKD activating mutation FDA accelerated approval 26/02/2026 (expands the indication to untreated patients). Source
Hernexeoszongertinib page
NSCLC Approved 2025 accelerated Not approved

Beamion LUNG-1 single-arm, 71 after platinum; 34 after platinum and a HER2 ADC
Response 75% (no prior HER2 drug); 44% (after a HER2 ADC) (63-83; 29-61)Lasting 58% and 27% of responses lasted 6 months or more

Serious side effects 36%Stopped for side effects 6%Fatal 0.6%

Trial details and side effects
Patients
HER2 TKD-mutant non-squamous NSCLC after systemic therapy (NCT04886804)
Most common side effects
diarrhoea 54%, rash 28%, liver toxicity 27%, fatigue 25%, nausea 23%, musculoskeletal pain 21%, upper respiratory infection 20% (177 patients)
Notes
FDA approval summary (2025). Boxed areas of warning: liver toxicity, heart function, interstitial lung disease. Side effects: Hernexeos US label, section 6 (Beamion LUNG-1; common side effects from 292 pooled patients).
Source
FDA approval summary

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.

TestSampleForTumourSince
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

DrugTypeActive trialsFurthest phaseLead 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

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.

DueTrialPhaseDrugsSponsor
2026-10 A Study of TAK-788 in Adults With Non-Small Cell Lung CancerNCT02716116 · 334 patients Phase 1/2 mobocertinib Takeda
2026-11 Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC PatientsNCT05532696 · 61 patients Phase 1/2 ABT-101 Anbogen Therapeutics
2026-12 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 TreatmentNCT06151574 · 428 patients Phase 3 zongertinib, pembrolizumab Boehringer Ingelheim
2026-12 Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain MetastasesNCT06250777 · 27 patients Phase 2 trastuzumab deruxtecan Yonsei University
2027-06 Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion MutationsNCT06514027 · 30 patients Phase 2 BEBT-109 Capsules BeBetter Med
2027-06 Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung CancerNCT06734182 · 25 patients Phase 2 disitamab vedotin Guangdong Provincial People's Hospital
2027-07 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid TumorsNCT07122063 · 266 patients Phase 1/2 SYS6045 CSPC
2027-08 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 PembrolizumabNCT07486817 · 60 patients Phase 2 zongertinib, pembrolizumab Boehringer Ingelheim
2027-08 A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung CancerNCT07283198 · 160 patients Phase 2 JSKN033 Injection Jiangsu Alphamab Biopharmaceuticals
2027-09 Trastuzumab Deruxtecan (T-DXd) for People With Brain CancerNCT06058988 · 30 patients Phase 2 trastuzumab deruxtecan Memorial Sloan Kettering Cancer Center

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

  1. Boehringer Ingelheim 5
  2. AstraZeneca 3
  3. Bayer 3
  4. Daiichi Sankyo 2
  5. Baili-Bio / SystImmune 1
  6. Jiangsu Hengrui 1
  7. Suzhou Puhe Pharmaceutical Technology 1
  8. BeBetter Med 1
  9. Jiangsu Alphamab Biopharmaceuticals 1
  10. Pfizer 1
  11. Anbogen Therapeutics 1
  12. BlossomHill Therapeutics 1
  13. CSPC 1
  14. Dizal Pharmaceuticals 1
  15. 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.

Status
Match

49 of 91 trials shown

  1. Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

    Recruiting Phase 3 Boehringer Ingelheim Started 2026Primary completion 2032-02 NCT07195695

    zongertinib FDApembrolizumabatezolizumabdurvalumabnivolumab

    HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor recepto…

    Non-small Cell Lung Cancer

  2. A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2025Primary completion 2027-12 NCT07178795

    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

  3. 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)

    Recruiting Phase 3 Bayer Started 2024Primary completion 2027-10 NCT06452277

    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

  4. A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations

    Recruiting Phase 3 Jiangsu Hengrui Started 2024Primary completion 2026-02 NCT06430437

    trastuzumab rezetecanpemetrexedpaclitaxelcarboplatincisplatin

    Subjects with central laboratory- confirmed functional HER2 mutations

    Non-Small Cell Lung Cancer With HER2- Mutations

  5. 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

    Active, not recruiting Phase 3 Boehringer Ingelheim Started 2024Primary completion 2026-12 NCT06151574

    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

  6. YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

    Not yet recruiting Phase 3 Suzhou Puhe Pharmaceutical Technology Started 2023Primary completion 2025-07 NCT05767892

    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)

  7. 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

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2026-06 NCT05048797

    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

  8. A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

    Not yet recruiting Phase 1/2 RemeGen Starts 2027Primary completion 2027-12 NCT05745740

    disitamab vedotinpyrotinib

    Documented HER2 exon 20 insertion mutation.

    Non-small Cell Lung Cancer

  9. A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.

    Not yet recruiting Phase 2 MedSIR Started 2026Primary completion 2028-09 NCT07619066

    zongertinib FDAfulvestrant

    Known activating HER2 mutation.

    Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation

  10. PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2026Primary completion 2027-12 NCT07416058

    iparomlimab and tuvonralimabpemetrexedbevacizumab

    and HER2 exon 20 insertions.

    Lung Adenocarcinoma

  11. 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

    Recruiting Phase 2 Boehringer Ingelheim Started 2026Primary completion 2027-08 NCT07486817

    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

  12. 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

    Not yet recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Started 2026Primary completion 2029-08 NCT07781202

    trastuzumab rezetecan

    Confirmed HER2 mutation (detected by PCR or NGS).

    HER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression

  13. 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)

    Recruiting Phase 2 Bayer Started 2025Primary completion 2029-02 NCT06760819

    sevabertinib FDA

    Documented activating HER2 mutation

    Advanced Solid Tumors, HER2 Mutation

  14. A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Jiangsu Alphamab Biopharmaceuticals Started 2025Primary completion 2027-08 NCT07283198

    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)

  15. Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

    Active, not recruiting Phase 1/2 CSPC Started 2025Primary completion 2027-07 NCT07122063

    SYS6045

    …metastatic solid tumors (excluding breast, colorectal, and NSCLC), with HER2 expressionor HER2 mutation.

    Advanced Solid Tumors

  16. A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

    Recruiting Phase 1/2 BlossomHill Therapeutics Started 2025Primary completion 2029-01 NCT06706076

    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)

  17. Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations

    Recruiting Phase 2 BeBetter Med Started 2024Primary completion 2027-06 NCT06514027

    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

  18. Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

    Recruiting Phase 2 Vanderbilt-Ingram Cancer Center Started 2024Primary completion 2030-04 NCT05919108

    neratinib

    …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

  19. Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer

    Recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024Primary completion 2027-06 NCT06734182

    disitamab vedotincarboplatin

    HER2 mutations identified by histological specimens;

    Non-small Cell Lung Cancer

  20. Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases

    Enrolling by invitation Phase 2 Yonsei University Started 2024Primary completion 2026-12 NCT06250777

    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

  21. A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

    Recruiting Phase 1/2 Yuhan Started 2024Primary completion 2028-03 NCT06616766

    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

  22. Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

    Recruiting Phase 2 Boehringer Ingelheim Started 2024Primary completion 2028-11 NCT06581432

    zongertinib FDA

    …ented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)

    Solid Tumours

  23. Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2027-09 NCT06058988

    trastuzumab deruxtecan FDA EU

    o Has a history of Her2 expression or activating Her2-mutation

    Brain Cancer, Glioblastoma, Metastatic Cancer, Leptomeningeal Metastasis

  24. Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

    Recruiting Phase 2 German Cancer Research Center Started 2023Primary completion 2030-03 NCT05332561

    atezolizumabinavolisibipatasertibolaparibsacituzumab govitecantrastuzumabpertuzumab

    Arm 6 (Trastuzumab / Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation

    Early-stage Breast Cancer

  25. A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2028-05 NCT05892068

    tucatinib

    …ymal progression in patients with HER2+/mutant lung/esophagogastric/colorectal cancer and HER2 mutant breast cancer

    Metastatic Breast Cancer

  26. 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

    Recruiting Phase 1/2 Pierre Fabre Medicament Started 2023Primary completion 2029-12 NCT06043817

    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

  27. A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

    Active, not recruiting Phase 2 AstraZeneca Started 2022Primary completion 2024-11 NCT05246514

    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

  28. Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

    Recruiting Phase 1/2 ORIC Pharmaceuticals Started 2022Primary completion 2026-09 NCT05315700

    ORIC-114carboplatinpemetrexed

    HER2 exon 20 insertion mutation

    Solid Tumors

  29. Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

    Recruiting Phase 1/2 Anbogen Therapeutics Started 2022Primary completion 2026-11 NCT05532696

    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

  30. Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

    Active, not recruiting Phase 2 Pfizer Started 2021Primary completion 2023-11 NCT04579380

    tucatinibtrastuzumabfulvestrant

    Known activating HER2 mutations detected in fresh or archival tumor tissue or blood

    Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms

  31. 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)

    Recruiting Phase 1/2 Bayer Started 2021Primary completion 2028-12 NCT05099172

    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

  32. A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

    Active, not recruiting Phase 2 AstraZeneca Started 2020Primary completion 2023-01 NCT04639219

    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

  33. Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

    Recruiting Phase 2 Dana-Farber Cancer Institute Started 2020Primary completion 2028-02 NCT04620187

    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

  34. Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

    Active, not recruiting Phase 1/2 Dizal Pharmaceuticals Started 2019Primary completion 2024-07 NCT03974022

    sunvozertinib

    …d histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.

    Non-Small Cell Lung Cancer

  35. A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Takeda Started 2016Primary completion 2026-10 NCT02716116

    mobocertinib

    A HER2 exon 20 insertion;

    Carcinoma, Non-Small-Cell Lung

  36. Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2021-01 NCT04439136

    afatinib

    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

  37. A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

    Recruiting Phase 1 Daiichi Sankyo Started 2025Primary completion 2028-12 NCT07015697

    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

  38. A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors

    Recruiting Phase 1 Cogent Biosciences Started 2025Primary completion 2028-05 NCT07361562

    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

  39. A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

    Recruiting Phase 1 Nuvalent Started 2024Primary completion 2027-01 NCT06521554

    NVL-330

    Phase 1b: Documented oncogenic HER2 mutation.

    Locally Advanced Solid Tumor, Metastatic Solid Tumor

  40. A Study of KM501 in Patients With Solid Tumors

    Not yet recruiting Phase 1 Xuanzhu Biopharmaceutical Started 2023Primary completion 2026-12 NCT05804864

    KM501

    Advanced non-small cell lung cancer with a HER2 mutation.

    Status may be outdated, last updated 2023-04-07Advanced Solid Tumors

  41. ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Enliven Therapeutics Started 2023Primary completion 2026-07 NCT05650879

    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

  42. 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

    Active, not recruiting Phase 1 ArriVent BioPharma Started 2022Primary completion 2025-06 NCT05364073

    furmonertinib

    …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

  43. Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2022Primary completion 2028-07 NCT05372614

    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

  44. 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)

    Active, not recruiting Phase 1 Boehringer Ingelheim Started 2021Primary completion 2026-12 NCT04886804

    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

  45. DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2020Primary completion 2025-07 NCT04042701

    trastuzumab deruxtecan FDA EUpembrolizumab

    Pathologically documented, locally advanced/metastatic HER2-mutant NSCLC

    Breast Cancer, Non-small Cell Lung Carcinoma

  46. Exercise to Improve Neurovascular Function in Breast Cancer Survivors

    Not yet recruiting No phase Baker Heart and Diabetes Institute Started 2025Primary completion 2026-07 NCT06925529

    Trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR

    Breast Cancer Survivorship

  47. 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

    Recruiting Phase 2 Shanghai Junshi Bioscience Started 2025Primary completion 2026-09 NCT06868836

    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

  48. HTL0039732 in Participants With Advanced Solid Tumours

    Recruiting Phase 1/2 Cancer Research UK Started 2023Primary completion 2028-12 NCT05944237

    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

  49. 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

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2013Primary completion 2015-08 NCT01708954

    cabozantiniberlotinib

    …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