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

Recruiting Phase 3 Interventional Study
Lung Adenocarcinoma Cryotherapy Effect
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
214 (estimated)
Sponsor
Institut Bergonié · Other
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About This Trial
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):…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed non-small lung adenocarcinoma. 2. Metastatic disease. 3. Treatment with pembrolizumab in combination with pemetrexed-carboplatin as per market authorization. 4. At least two target lesions (RECIST1.1), measurable with CT or MRI : …
Contacts

Jean PALUSSIERE, MD

05.56.33.33.47

j.palussiere@bordeaux.unicancer.fr

CONTACT

Simone MATHOULIN-PELISSIER, MD, PhD

s.mathoulin@bordeaux.unicancer.fr

CONTACT