OncoMatch/Clinical Trials/NCT06123754
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Is NCT06123754 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous for non-small cell lung cancer.
Treatment: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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.
Frequently asked questions
Is NCT06123754 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 ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIA or IIIB (N2) is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify