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?
Participants who are able to comply with the requirements and restrictions listed in the Informed Consent Form and the study protocol (there is no separate Informed Consent Form for entering the maintenance phase)
Signature of the informed consent form for those patients who have not previously participated to the induction phase of the study
Age greater than or equal to 18 years and less than or equal to 75 years
Willingness and ability to comply with the prescribed cyclic, 5-day calorie restriction regimen, the scheduled visits, treatment plans, laboratory tests and other procedures
Prior systemic treatment for ES SCLC, with the exception for first-line chemoimmunotherapy induction with 4 triweekly cycles of atezolizumab plus carboplatin and etoposide. Patients who received prior concurrent chemoradiotherapy for limited-stage (LS) disease may be enrolled if concurrent chemoradiotherapy was concluded at least three months before enrollment.
Patient has not available archival tumor tissue or has only cytological material without cytoincluded material available.
The patient has not recovered from immune-related AEs of grade 2 or higher from the induction phase with atezolizumab plus carboplatin and etoposide. Patients with adequately-treated, controlled, immune-related skin rash of grade 2 or adequately-treated, controlled, endocrinopathies of grade 2 on replacement therapy can be enrolled.
Body mass index (BMI) < 19 kg/m2.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
IFOM ETS - The AIRC Institute of Molecular Oncology
Collaborator
University of Milan
Collaborator