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

Study acronym: ADAPTABLE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Sep 2025 to Jun 2, 2025v4
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 43 to 44 · Eligibility criteria expanded, about 75 wordsv3 Show 2 more changesShow less
    • Study sites: 43 to 44
    • Eligibility criteria expanded, about 75 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2023 to Apr 26, 2023 · Site details revised at 43 of 43 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2023 to Apr 26, 2023
    • Site details revised at 43 of 43 sites
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05781308
Lead Sponsor Intergroupe Francophone de Cancerologie Thoracique
Conditions Non Small Cell Lung Cancer
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov