Phase III Study of Toripalimab Versus Placebo Plus Chemotherapy in Resectable NSCLC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

501

Participants

Timeline

Start Date

April 7, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Stage II-III Non-small Cell Lung Cancer
Interventions
DRUG

4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab

Biological: Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W

DRUG

4cycles(Placebo + platinum-based doublet chemotherapy)+13 cycles(Placebo )

Biological: Placebo by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W

Trial Locations (1)

Unknown

Shanghai Chest Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Junshi Bioscience Co., Ltd.

OTHER