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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT05703997
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclic, 5-day calorie restriction — DIETARY_SUPPLEMENT
    Cyclic, 5-day, calorie-restricted (about 600 Kcal on day 1; about 300 Kcal on days 2 to 5), plant-based, low-protein, low-carbohydrate diet.
  • Atezolizumab — DRUG
    Atezolizumab 1200 mg administered intravenously.

Study Details

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?

Key Dates

Start date
Jan 31, 2023
Status verified
Dec 2022
Primary completion
Jan 31, 2025
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Maintenance treatment with cyclic, 5-day calorie restriction plus atezolizumab
    The experimental maintenance treatment will consist of: * triweekly cycles of 5-day calorie restriction (on days -2 through 2 of each cycle) in combination with * atezolizumab (at a dose of 1200 mg, administered intravenously on day 0 of each cycle) The experimental maintenance treatment will be administered until the occurrence of unacceptable toxic effects, disease progression, consent withdrawal or patient death. Patients interrupting cyclic calorie restriction for any reason other than disease progression may continue the maintenance treatment with atezolizumab alone, if clinically indicated.

Primary Outcome Measure

PFS rate at 6 months [ Time Frame: 6 months from experimental maintenance treatment initiation ]

Central Contacts

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