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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Targeted therapy

Envafolimab injections+intravenous Disitamab Vedotin+carboplatin

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06734182 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 mutation is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR sensitizing mutation is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK fusion is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or IIIA or IIIB is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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