NCT04316364

A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 placebo and monitoring.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin	Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
DRUG	SHR-1316、Chemotherapeutic	Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
DRUG	Placebo、Chemotherapeutic	Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert

Timeline

• Start date: 2020-07-14
• Primary completion: 2023-04-15
• Completion: 2026-12-15
• First posted: 2020-03-20
• Last updated: 2021-11-04

Locations

7 sites across 1 country: China