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

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.

Trial Details

NCT ID
NCT06123754
Phase
PHASE3
Sponsor
3D Medicines (Sichuan) Co., Ltd.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
  • placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection
Locations (sample)
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • Volunteer to participate and sign the informed consent form.
  • Age ≥ 18 years old, regardless of gender.
  • Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.
  • Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.

For full eligibility, visit ClinicalTrials.gov.

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