drugset / Trial / NCT04564157

New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy

NCT04564157 ↗

Phase 3 Active not recruiting 210 enrolled Fundación GECP
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial. 210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy)

Timeline

Start
2021-01-13
Primary completion
2030-04-01
Completion
2031-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule 200 mg/m2 —