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Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma

Study acronym: CRYOMUNE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 30, 2026 (before its estimated August 27, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Aug 2023 to Aug 27, 2026
    • Study completion date: Aug 2025 to Aug 27, 2028
    • Study description expanded, about 4 words
    v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Enrollment target: 126 to 214
    • Primary completion date: Jun 2021 to Aug 2023
    • Study sites: 0 to 1
    • Study completion date: Jun 2025 to Aug 2025
    • Start date changed from estimate of Jun 2020 to Aug 28, 2020
    • Study description expanded, about 439 words
  4. Interventions: Cryoablation (Device), Pembrolizumab (Drug) to Carboplatin (Drug), Cryoablation (Device), Pembrolizumab (Drug), Pemetrexed (Drug)v3
  5. Study title shortened, about 6 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients. This is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial. Patients will be randomized with a 1:1 ratio into: * Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. * Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. Pembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization. Cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.
Trial Details
NCT Number NCT04339218
Lead Sponsor Institut Bergonié
Conditions
(from sponsor)		 Lung Adenocarcinoma, Cryotherapy Effect
Related terms Adenocarcinoma of Lung
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov