Overview

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

Status:
Not yet recruiting

Trial end date:
2029-01-01

Target enrollment:

Participant gender:

Summary

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?

Phase:

Phase 2

Details

Lead Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborators:

IFOM, The FIRC Institute of Molecular Oncology
University of Milan

Treatments:

Atezolizumab