The goal of this clinical trial is to learn if a combination of atezolizumab and standard chemotherapy works to treat sensitive Extensive-stage Small Cell Lung Cancer, progressing after first-line of treatment. The main questions it aims to answer are: * Does combination of atezolizumab and standard chemotherapy increase overall survival? * What medical problems do participants have when taking combination of atezolizumab and standard chemotherapy? Participants will: * take atezolizumab and standard chemotherapy every 3 weeks for 4 cycles and than atezolizumab every 3 weeks up to 18 cycles. * visit the clinic once every 3 weeks for checkups and tests * perform Radiological assessments after 6 weeks and then every 12 weeks to determine response to treatment.
The CARRY-ON study is a multicenter, prospective, open-label single-arm phase II trial, designed to seek for a signal of efficacy of continuing PD-L1 inhibition in patients with sensitive relapse ES-SCLC by adding atezolizumab to rechallenge carboplatin-etoposide chemotherapy. The trial is planned to enroll 142 patients with sensitive relapse ES-SCLC from 25 Italian centers. Sensitive relapse is defined as SCLC relapsed or progressed to first-line chemo-immunotherapy with PD-L1 inhibition (with either atezolizumab or durvalumab) at least 60 days after the last chemotherapy administration. Eligible patients will receive re-challenge chemotherapy (either carboplatin AUC 4 on day 1 plus etoposide 80 mg/m2 days 1-3 or carboplatin AUC 5 on day 1 plus etoposide 100 mg/m2 days 1-3, at investigator's choice) plus atezolizumab 1200 mg flat dosing on day 1 every 3 weeks until PD, unacceptable toxicity or to a maximum of 4 cycles (induction phase) followed by atezolizumab 1200 mg flat dosing every 3 weeks (maintenance phase) until completion of 1 year of maintenance (up to 18 cycles), progressive disease, unacceptable toxicity, patient refusal or loss of clinical benefit (investigator's choice), whichever occur first. Subjects will attend clinical visits at regular intervals to receive trial treatment and for efficacy and safety assessments. All subjects will be monitored continuously for any AE while on study treatment. Radiological assessment will be performed by computed tomography (CT) scan at week 6 (± 7 days), at week 12 (± 7 days) and every 12 weeks (± 7 days) thereafter. The duration of the study is expected to be a maximum of 45 months. The study recruitment period is expected to be approximately 24 months, maximum treatment duration will be 15 months (3 months of induction and 12 months of maintenance), and subsequent survival follow-up will be a maximum of 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
142
1200 mg IV on day 1 of every 21 days, during induction phase and maintenance phase
AUC 4 or 5, depending on patient's characteristics, on day 1 every 21 days during induction phase
80 mg/sqm or 100 mg/sqm, depending on patient's characteristics, on days 1-2-3 of every 21 days
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano (PN), Italy
NOT_YET_RECRUITINGIRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
NOT_YET_RECRUITINGIRCCS Azienda Ospedaliero_Universitaria di Bologna
Bologna, Italy
RECRUITINGUOC Medicina Oncologica
Carpi, Italy
overall survival
overall survival (OS), defined as the time from the date of registration to the date of death from any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive.
Time frame: through study completion, an average of 1 year
frequency of adverse events
Toxicity will be assessed in the mITT population. Descriptive tables will be produced which provide the worst degree of toxicity measured over all cycles according to the NCI-CTCAE version 5.0
Time frame: 30 days post last dose of study drug
Progression Free Survival
Progression Free Survival (PFS) defined as the time from the patient registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free and alive.
Time frame: through study completion, an average of 6 months
Objective response rate
Objective response rate (ORR) is calculated as the sum of RECIST v1.1-defined CR and PR out of the number of assessable patients with measurable disease at baseline.
Time frame: through study completion, an average of 1 year
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ASST Cremona
Cremona, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera S. Croce e Carle di Cuneo
Cuneo, Italy
NOT_YET_RECRUITINGAOU Careggi
Florence, Italy
NOT_YET_RECRUITINGAzienda USL Toscana nord-ovest Ospedale Versilia
Lido di Camaiore, Italy
RECRUITINGAzienda USL Toscana Nord Ovest - Ospedale San Luca
Lucca, Italy
NOT_YET_RECRUITINGIstituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) "Dino Amadori"
Meldola (FC), Italy
NOT_YET_RECRUITING...and 15 more locations