NCT04339218: CRYOMUNE

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

Recruiting now Phase 3 Last updated 30 January 2026

What this trial tests

Phase 3 trial testing Cryoablation in Lung Adenocarcinoma in 214 participants. Currently enrolling.

Timeline

28 August 2020

Primary endpoint
27 August 2026

27 August 2028

Quick facts

Lead sponsor	Institut Bergonié
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	214
Start date	28 August 2020
Primary completion	27 August 2026
Estimated completion	27 August 2028
Sites	1 location across France

Drugs / interventions tested

• Cryoablation
• Pembrolizumab (pembrolizumab) — full drug profile →
• Pemetrexed — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →

Conditions studied

• Lung Adenocarcinoma — all drugs for Lung Adenocarcinoma →
• Cryotherapy Effect — all drugs for Cryotherapy Effect →

Sponsor

Institut Bergonié — full company profile →

Who can join

18 and older, any sex, with Lung Adenocarcinoma or Cryotherapy Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Thermal ablation in non-small cell lung cancer: a review of treatment modalities and the evidence for combination with immune checkpoint inhibitors.
   Rangamuwa K, Leong T, Weeden C, Asselin-Labat ML, et al · · 2021 · cited 65× · PMID 34295682 · DOI 10.21037/tlcr-20-1075
2. Cryoablation and immunity in non-small cell lung cancer: a new era of cryo-immunotherapy.
   Velez A, DeMaio A, Sterman D. · · 2023 · cited 21× · PMID 37671163 · DOI 10.3389/fimmu.2023.1203539
3. Clinical application status and prospect of the combined anti-tumor strategy of ablation and immunotherapy.
   Yin L, Li XY, Zhu LL, Chen GL, et al · · 2022 · cited 15× · PMID 36131929 · DOI 10.3389/fimmu.2022.965120
4. Modern cancer therapy: cryoablation meets immune checkpoint blockade.
   Liu Q, Zhang C, Chen X, Han Z. · · 2024 · cited 12× · PMID 38384806 · DOI 10.3389/fonc.2024.1323070
5. Contribution of immune cells in synergistic anti-tumor effect of ablation and immunotherapy.
   He N, Jiang J. · · 2024 · cited 8× · PMID 38070356 · DOI 10.1016/j.tranon.2023.101859
6. Combining energy-based focal ablation and immune checkpoint inhibitors: preclinical research and clinical trials.
   Jiang M, Fiering S, Shao Q. · · 2023 · cited 7× · PMID 37251920 · DOI 10.3389/fonc.2023.1153066
7. CRYOVATE: A Pilot Study of Lung Cancer Cryoactivation in Combination With Immunotherapy in Advanced NSCLC.
   Desilets A, Pinheiro G, Belkaid W, Salko O, et al · · 2024 · cited 5× · PMID 39624249 · DOI 10.1016/j.jtocrr.2024.100737
8. Abscopal effect induced by cryoablation in a 55-year-old patient with metastatic dedifferentiated liposarcoma: a case report.
   Wetterwald L, Papadopoulos S, Tsoumakidou G, Boughdad S, et al · · 2024 · cited 5× · PMID 39507450 · DOI 10.21037/atm-23-1868