Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in First-line Treatment for Patients With Metastatic Lung Adenocarcinoma: A Randomized Phase III Study
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.
• Histologically or cytologically confirmed non-small lung adenocarcinoma.
• Metastatic disease.
• Treatment with pembrolizumab in combination with pemetrexed-carboplatin as per market authorization.
• At least two target lesions (RECIST1.1), measurable with CT or MRI :
∙ One target lesion that is amenable for accurate repeated measurements,
‣ 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.
• Age ≥ 18.
• Performance status ≤ 2.
• Women of childbearing potential must have a negative serum pregnancy test prior to registration.
• Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia)
• Patients with a social security in compliance with the French law (Loi Jardé).
⁃ Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
⁃ Voluntarily signed and dated written informed consents prior to any study specific procedure.