The study of second-line durvalumab plus tremelimumab vs. platinum-based chemotherapy for NSCLC

The company AIO-Studien-gGmbH is commencing recruitment for the clinical trial of the Randomized Phase II, Open-label Efficacy and Safety Study of Second-line Durvalumab Plus Tremelimumab Versus Platinum-based Chemotherapy Alone in Patients With NSCLC and First-line Checkpoint-inhibitor Therapy (Re-Check).

The condition is NSCLC Stage IV.

A new clinical trial is recruiting patients in the following locations: Germany.

The trial officially began on the May 2022 and is planned to complete on May 2026.

This is an open label, randomized, Phase II multicenter study designed to evaluate the safety and efficacy of two different second-line strategies: After failure of first line mono-immunotherapy with checkpoint inhibitors (anti-PD-1/PD-L1), and subsequent 2 cycles of standard of care platinum-based chemotherapy, 2 treatment arms will be compared: Arm A (Experimental Arm): After randomization, patients will receive a combination regimen featuring a single, priming dose of tremelimumab together with conventional durvalumab dosing.

Durvalumab maintenance therapy will subsequently be continued as study treatment for up to 12 cycles. Arm B: After randomization, patients will continue to receive another 2-4 cycles of platinum-based chemotherapy. Afterwards, patients will end treatment or receive maintenance pemetrexed therapy as per marketing authorization (depending on histology, maximum of 13 cycles) at the discretion of the investigator.

AstraZeneca is the collaborator in this clinical trial.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05383001.

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