OncoMatch

OncoMatch/Clinical Trials/NCT06123754

Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC

Is NCT06123754 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous for non-small cell lung cancer.

Phase 3Recruiting3D Medicines (Sichuan) Co., Ltd.NCT06123754Data as of May 2026

Treatment: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenousThis is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Required: EGFR wild-type

Disease stage

Required: Stage IIIA, IIIB (N2)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: T cell receptor-targeted therapy

Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.)

Cannot have received: anti-tumor therapy

Previous anti-tumor therapy for the disease

Lab requirements

Blood counts

Sufficient organ and bone marrow function

Kidney function

Liver function

Sufficient organ and bone marrow function

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

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