Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma
Trial Parameters
Brief Summary
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.
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 : 1. One target lesion that is amenable for accurate repeated measurements, 2. One target lesion (15-40 mm) that is amenable for cryoablation treatment including lung, kidney, adrenal, soft tissue and lytic bone lesions. Liver and sclerotic bone lesions are not allowed to be treated by cryoablation. 5. Age ≥ 18. 6. Performance status ≤ 2. 7. Women of childbearing potential must have a negative serum pregnancy test prior to registration. 8. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia) 9. Patients with a social security in compliance with the French law (Loi Jardé). 10. Patients must be willing and able to comply with scheduled visits, treatment pl