OncoMatch/Lung Cancer — Non-Small Cell (NSCLC)/HER2 (ERBB2)

Lung Cancer — Non-Small Cell (NSCLC)HER2 (ERBB2) Clinical Trials

34 recruiting trials·Updated daily from ClinicalTrials.gov

HER2 (ERBB2) mutations — most commonly exon 20 insertions — are found in 2–4% of NSCLC. Trastuzumab deruxtecan (T-DXd) received accelerated FDA approval for HER2-mutant NSCLC in 2022. Active trials investigate additional HER2-directed agents, bispecific antibodies, and strategies targeting the spectrum of HER2 alterations including amplification and overexpression.

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Top recruiting

Top recruiting HER2 (ERBB2) Lung Cancer — Non-Small Cell (NSCLC) trials

Ranked by phase and US site count.

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Phase 323 US sites

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Boehringer Ingelheim

Phase 318 US sites

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Daiichi Sankyo

Phase 3

Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated

Intergroupe Francophone de Cancerologie Thoracique

Phase 3

D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC

Guangdong Provincial People's Hospital

Phase 2/Phase 3

DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations

Cancer Research UK

Phase 2267 US sites

Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

SWOG Cancer Research Network

Additional trials

More HER2 (ERBB2) Lung Cancer — Non-Small Cell (NSCLC) trials

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Phase 2

NCT06706076A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 MutationsPhase 1/Phase 221 US sites NCT06043817First-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 MutationsPhase 1/Phase 29 US sites NCT07428044A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung CancerPhase 29 US sites NCT07012031Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C MutationPhase 1/Phase 24 US sites NCT07250477Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung CancerPhase 21 US site NCT07111520A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)Phase 1/Phase 21 US site NCT06616766A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946Phase 1/Phase 21 US site NCT03526835A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid TumorsPhase 1/Phase 223 US sites NCT06695845A Phase 2 Study of Zanidatamab in Patients With HER2-expressing TumorsPhase 216 US sites

Phase 1

NCT06625775Open-Label Study of BBO-10203 in Subjects With Advanced Solid TumorsPhase 119 US sites NCT04686305Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLCPhase 113 US sites NCT07361562A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid TumorsPhase 16 US sites NCT05681780Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLCPhase 11 US site

11 international trials (no US sites)

NCT06563999Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.Phase 2 NCT05800340Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLCPhase 2 NCT06749860Disitamab 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/expressionPhase 2 NCT07192068Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.Phase 2 NCT07467863Dual-Target CAR-NK Cells Directed Against MSLN, EGFR, or HER2 in Advanced NSCLCPhase 1/Phase 2 NCT06496490A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene AbnormalityPhase 2 NCT06734182Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung CancerPhase 2 NCT05751018Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung CancerPhase 2 NCT06114511A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung CancerPhase 1/Phase 2 NCT05532696Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC PatientsPhase 1/Phase 2 NCT03198052GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against CancersPhase 1

Related therapies

FDA-approved therapies for HER2 (ERBB2) Lung Cancer — Non-Small Cell (NSCLC)

Approved agents for this molecular target. Indication labels specify the approved patient population — some approvals apply to specific variants only.

Trastuzumab DeruxtecanHER2-directed antibody-drug conjugateHER2-mutant (activating mutation) unresectable or metastatic NSCLC

Other Lung Cancer — Non-Small Cell (NSCLC) biomarkers

Browse other molecular targets with active Lung Cancer — Non-Small Cell (NSCLC) trials.

EGFR ALK ROS1 PD-L1 (CD274)KRAS MET BRAF RET NTRK1 NTRK2 NTRK3

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