FASTing-like approach to improve the efficacy of maintenance IMMunotherapy in Extensive-stage small cell lung cancer patients not progressing on chemoimmunotherapy induction: the FASTIMMUNE trial.

PI: Dr. Claudio Vernieri  

Multicenter, open-label, single-arm, non-profit, phase II clinical trial with a two-stage Simon design. The study includes two parts: a first induction part with standard chemo-immunotherapy and a second part of experimental maintenance treatment with immunotherapy in combination with cyclic severe caloric restriction. Patients with aSCLC eligible after screening will receive standard chemo-immunotherapy with carboplatin, etoposide and atezolizumab for 4 cycles. During the induction phase, information about the nutritional profile of the patients will be collected and blood, stool and urine samples will be collected at specific time points. This will then lead to the experimental maintenance phase with three-weekly cycles of cyclic severe caloric restriction (from day -2 to day 2 of each cycle) and atezolizumab until disease progression, unacceptable toxicity, withdrawal of consent or death of the patient.