Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Tr… (NCT04339218) | Clinical Trial Compass
RecruitingPhase 3
Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma
France214 participantsStarted 2020-08-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma or incidentally discovered good prognosis prostate cancer (T stage \< pT3 and Gleason ≤ 7).