NCT04772287

Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008)

Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 341 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, double-blind, single-center Phase III clinical study in patients with EGFR/ALK mutation negative stage II-IIIB (N2) non-small cell lung cancer (NSCLC) after complete tumor resection. To evaluate the effectiveness and safety of toripalimab compared with placebo combined with platinum-containing dual-drug chemotherapy.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.
DRUG	Toripalimab mimetic (placebo)	Placebo: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.

Timeline

• Start date: 2021-03-31
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2021-02-26
• Last updated: 2021-02-26