This is a phase IIIB, single-arm, single-country, multicenter study of the safety and efficacy of atezolizumab in combination with carboplatin plus etoposide in patients who have ES-SCLC and are chemotherapy-naive for their extensive-stage disease.
Induction treatment will be administered on a 21-day cycle for four/six cycles. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Maintenance with atezolizumab will continue until disease progression (PD), unacceptable toxicity or loss of clinical benefit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After the induction phase, participants will begin maintenance therapy with atezolizumab every 3 weeks.
Carboplatin will be administered after completion of atezolizumab by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min (Calvert formula dosing) with standard anti-emetics per local practice guidelines.
Etoposide will be administered by IV infusion over 60 minutes following carboplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.
Incidence of Serious Adverse Events
Time frame: 4 weeks after last dose of study treatment
Incidence of Serious and Non-Serious Immune Mediated Adverse Events
Time frame: 4 weeks after last dose of study treatment
Overall Survival (OS) Rate at 1 Year
OS at 1 year, defined as the proportion of participants remaining alive at 1 year after initiation of study treatment.
Time frame: 1 Year
Overall Survival (OS) Rate at 2 Years
OS at 2 years, defined as the proportion of participants remaining alive at 2 years after initiation of study treatment.
Time frame: 2 Years
Overall Survival (OS) Rate at 3 Years
OS at 3 years, defined as the proportion of participants remaining alive at 3 years after initiation of study treatment.
Time frame: 3 Years
Overall Survival (OS) Rate
OS, defined as the time from initiation of study treatment to death from any cause
Time frame: Up to approximately 54 months
Progression-Free Survival (PFS)
PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to approximately 54 months
Objective response rate (ORR)
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Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
Lecce, Apulia, Italy
Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica
Rionero in Vulture (PZ), Basilicate, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino, Campania, Italy
Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia
Naples, Campania, Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
Naples, Campania, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
Aviano, Friuli Venezia Giulia, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, Italy
...and 15 more locations
ORR, defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.
Time frame: Up to approximately 54 months
Duration of Response (DOR)
Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time frame: Up to approximately 54 months