Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy — ADAPTABLE  

Non Small Cell Lung Cancer Clinical Trial

Official title: A Non-comparative Randomized Phase II Trial Evaluating the Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced Non-squamous NSCLC Progressing After Immunotherapy and Chemotherapy

Status Recruiting

Clinical Trial Summary

This is an open-label, randomized, non-comparative, multicentre, phase II study in which NSCLC patients who have progressed following chemotherapy and immunoptherapy are randomized to receive treatment with either paclitaxel and bevacizumab (Arm A), or paclitaxel, bevacizumab and atezolizumab (Arm B). An estimated 156 patients (52 in Arm A, 104 in Arm B) will be enrolled at approximately 40 centres. Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. For patients in Arm B, continuation of atezolizumab beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 6 months ≤ 50% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 66% or more of patients in Arm B would achieve progression free survival at 6 months.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

• NCT number: NCT05781308
• Study type: Interventional
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: Opérations Cliniques
• Phone: +33156811045
• Email: contact@ifct.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: April 26, 2023
• Completion date: June 2026