Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Sponsor: 3D Medicines (Sichuan) Co., Ltd.
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
Conditions
Interventions
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.
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