Clinical Trial: NCT04158440
Phase III Study of Toripalimab Versus Placebo Plus Chemotherapy in Resectable NSCLC
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Shanghai Junshi Bioscience Co., Ltd. |
| Information Provided By: | Shanghai Junshi Bioscience Co., Ltd. |
| Last Update Posted: | 2026-07-23 |
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer
Conditions
Stage II-III Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab
- Drug: 4cycles(Placebo + platinum-based doublet chemotherapy)+13 cycles(Placebo )
Other Study ID Numbers
- JS001-029-III-NSCLC
Start Date (Actual)
2020-04-07
Primary Completion Date (Actual)
2026-04-18
Study Completion Date (Actual)
2026-07-03
Enrollment (Actual)
501
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Shanghai Junshi Bioscience Co., Ltd. |
| Information Provided By: | Shanghai Junshi Bioscience Co., Ltd. |
| Last Update Posted: | 2026-07-23 |
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer
Conditions
Stage II-III Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab
- Drug: 4cycles(Placebo + platinum-based doublet chemotherapy)+13 cycles(Placebo )
Other Study ID Numbers
- JS001-029-III-NSCLC
Start Date (Actual)
2020-04-07
Primary Completion Date (Actual)
2026-04-18
Study Completion Date (Actual)
2026-07-03
Enrollment (Actual)
501
Study Type
Interventional
Phase
Phase 3