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

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT05781308
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m² every 3 weeks
  • Bevacizumab — DRUG
    Bevacizumab 15 mg/kg every 3 weeks
  • Atezolizumab — DRUG
    1200 mg every 3 weeks

Study Details

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.

Key Dates

Start date
Apr 26, 2023
Status verified
Nov 2025
Primary completion
Jun 2, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A: paclitaxel + bevacizumab
    Bevacizumab 15 mg/kg and paclitaxel 200 mg/m² intravenously every three weeks until progression.
  • Experimental: Arm B: paclitaxel + bevacizumab + atezolizumab
    Atezolizumab 1200 mg, bevacizumab 15 mg/kg and paclitaxel 200 mg/m² intravenously every three weeks until progression.

Primary Outcome Measure

Progression Free Survival at 6 months determined by independent reviewer [ Time Frame: 6 months after randomization ]

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