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

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.

Timeline

Start

2023-04-26

Primary completion

2025-06-02

Completion

2026-06

Drugs

Indications