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.
Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015) confirmed at pathology (histology or cytology).
Male or female and ≥ 18 years of age.
Life expectancy ≥ 12 weeks.
Disease progression at least 60 days after the completion of first-line chemotherapy consisting of at least 4 cycles of platinum-etoposide plus either atezolizumab or durvalumab and have not received any other treatment (except for immunotherapy as maintenance treatment); the 60 day-interval is calculated from the date of the last chemotherapy administration to the date of the first radiologically documented progressive disease.
Recovered (i.e., ≤ grade 1 toxicity) from effects of prior anticancer therapy, except alopecia.
Prior radiotherapy is allowed provided that it has been completed more than 2 weeks before starting protocol treatment and patients have recovered from AEs related to radiotherapy to < grade 1
Ability to comply with protocol requirements.
The patient or the patient's legal representative has to be able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Single group
Atezolizumab
Drug1200 mg IV on day 1 of every 21 days, during induction phase and maintenance phase
Carboplatin
DrugAUC 4 or 5, depending on patient's characteristics, on day 1 every 21 days during induction phase
Etoposide
Drug80 mg/sqm or 100 mg/sqm, depending on patient's characteristics, on days 1-2-3 of every 21 days
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.
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
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.
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.
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Gruppo Oncologico Italiano di Ricerca Clinica
Lead sponsor
Roche Pharma AG
Collaborator
