drugset / Trial / NCT07153445

Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)

NCT07153445 ↗

Phase 2 Recruiting 97 enrolled Fundación GECP
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled. The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not. Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.

Timeline

Start
2025-07-08
Primary completion
2035-05-02
Completion
2035-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody — Intravenous
Subject Carboplatin Small molecule — Intravenous
Subject Paclitaxel Small molecule — Intravenous