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.
One target lesion that is amenable for accurate repeated measurements,
Squamous cell tumors and other than adenocarcinoma.
Prior systemic treatment for advanced non-small cell lung cancer (except adjuvant therapy after complete resection).
Current or prior use of immunosuppressive medication including any use of oral glucocorticoids, within 21 days before the first dose of pembrolizumab.
Known contra-indication and/or hypersensitivity to PD1/PD-L1 antagonist and/or cytotoxic therapy.