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Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

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

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 16 → 12 locations
    v6
  2. Study sites: 17 to 16v5
  3. Site details revised at 7 of 17 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Jan 14, 2025
    • Site details revised at 17 of 17 sites
    v3
  5. Start date: Oct 2024 to Dec 2024
    • Study sites: 0 to 17
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment. Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.
Trial Details
NCT Number NCT06219317
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions
(from sponsor)		 NSCLC Stage IV
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov