Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- MPR by BIPR — Up to 5 years
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy (evaluated by BIPR) - EFS by BIRC — Up to 5 years
EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression (BIRC assessment based on RECIST 1.1) or recurrence/metastasis, or death from any cause.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tianjin cancer hospital | Tianjin | Tianjin Municipality | Recruiting |
More 3D Medicines (Sichuan) Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06123754 on ClinicalTrials.gov ↗ ← All trials in China