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.
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