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RECRUITING
NCT06123754
PHASE3

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

Sponsor: 3D Medicines (Sichuan) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2023-11-17

Completion Date

2027-12-30

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection

The subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.It will last about 3-4 cycles before surgery and 16 cycles after surgery.

DRUG

placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection

The subjects received platinum-based doublet chemotherapy on day 1 of every cycle. It's 3 weeks per cycle and lasts 3-4 cycles before surgery.

Locations (1)

Tianjin cancer hospital

Tianjin, Tianjin Municipality, China