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OncoMatch/Clinical Trials/NCT06734182

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

Is NCT06734182 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Envafolimab injections+intravenous Disitamab Vedotin+carboplatin for non-small cell lung cancer.

Phase 2RecruitingGuangdong Provincial People's HospitalNCT06734182Data as of May 2026

Treatment: Envafolimab injections+intravenous Disitamab Vedotin+carboplatinThis 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, stage II-IIIB, NSCLC.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) mutation

HER2 mutations identified by histological specimens

Required: EGFR sensitizing mutation

Participants with known EGFR sensitive mutations

Required: ALK fusion

Participants with known...ALK translocation

Required: KRAS sensitizing mutation

KRAS sensitive mutations

Required: BRAF V600E

BRAF V600E

Required: ROS1 fusion

ROS1 fusions

Required: RET fusion

RET fusions

Required: MET exon 14 alteration

MET exon 14 alterations

Required: MET amplification

MET amplification

Required: NTRK1 fusion

NTRK fusions

Required: NTRK2 fusion

NTRK fusions

Required: NTRK3 fusion

NTRK fusions

Disease stage

Required: Stage II, IIIA, IIIB (AJCC version 9)

Excluded: Stage IIIC

resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC; unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic antitumor therapy

Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product

Cannot have received: PD-1/PD-L1 agent or drug acting on another targeted T cell receptor

Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40)

Lab requirements

Blood counts

Adequate organ function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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