FASTing-like Approach and Maintenance IMMunotherapy in ES-SCLC Patients Not Progressing on Chemoimmunotherapy Induction

Cyclic, 5-day calorie restriction is a safe metabolic intervention when combined with standard therapies in cancer patients, favorably reshaping peripheral blood and intratumor metabolism and immunity in a way that may improve the antitumor activity and efficacy of immunotherapy. The goal of this clinical trial is to test if combining cyclic, 5-day calorie restriction with atezolizumab maintenance in patients with ES SCLC achieving at least stable disease after four cycles of induction atezolizumab plus carboplatin and etoposide chemoimmunotherapy may increase the efficacy of a standard first-line, chemo-immunotherapy approach in terms of patient PFS. The main question it aims to answer is: • does the combination of cyclic, 5-day calorie restriction with triweekly atezolizumab increase the 6 months PFS rate, as evaluated from maintenance treatment initiation, compared to historical results with standard atezolizumab maintenance monotherapy in patients with ES SCLC non-progressive after four cycles of first-line chemo-immunotherapy induction with atezolizumab plus carboplatin and etoposide?

NCT Number	NCT05703997
Lead Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Collaborators: IFOM ETS - The AIRC Institute of Molecular Oncology, University of Milan
Conditions	Small Cell Lung Carcinoma
Enrollment	20 participants
Start Date	2023-01
Primary Completion	2025-01 (estimated)
Study Completion	2029-01 (estimated)
Updated on ClinicalTrials.gov	2023-01-30