drugset
drugset / Trial / NCT05116462

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

NCT05116462 ↗

Phase 3 Active not recruiting 506 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

Timeline

Start
2024-03-15
Primary completion
2026-09-30
Completion
2028-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma