A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or best supportive care and monitoring.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ib/III, Double-blinded, Multicentre, Randomized Study of SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment in Resectable Stages II and III Non-small Cell Lung Cancer
Actual Study Start Date: July 14, 2020
Estimated Primary Completion Date: May 2025
Estimated Study Completion Date: May 2026
Arm:
- Experimental: Treatment group A
- Placebo Comparator: Treatment group B
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 456 |
| Actual Study start date | 14 July 2020 |
| Estimated Study Completion Date | 01 May 2026 |