This is a phase II, single-arm, multicenter study to evaluate the activity and safety of durvalumab in combination with carboplatin or cisplatin plus etoposide in patients with treated ES-EPSCC.
All drugs will be administered intravenously. Induction treatment will be administered on a 21-day cycle for four cycles and will consist of: * etoposide 80-100 mg/m² (administered on days 1-3 of each 21-day cycle); * investigator's choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m² (administered on day 1 of each cycle); * durvalumab 1500 mg every 3 weeks in combination with chemotherapy (induction phase) followed by maintenance phase with durvalumab 1500 mg every 4 weeks. Patients will continue treatment until disease progression per investigator assessment, unacceptable toxicity, or other discontinuation criteria were met for a maximum of 24 months. Continuation of study treatment after disease progression will be permitted if there is evidence of clinical benefit for a maximum 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
All drugs will be administered intravenously. Induction treatment will be administered on a 21-day cycle for four cycles and will consist of: * etoposide 80-100 mg/m² (administered on days 1-3 of each 21-day cycle); * investigator's choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m² (administered on day 1 of each cycle); * durvalumab 1500 mg every 3 weeks in combination with chemotherapy (induction phase) followed by maintenance phase with durvalumab 1500 mg every 4 weeks. Patients will continue treatment until disease progression per investigator assessment, unacceptable toxicity, or other discontinuation criteria were met for a maximum of 24 months. Continuation of study treatment after disease progression will be permitted if there is evidence of clinical benefit for a maximum 24 months.
AUSL-IRCCS of Reggio Emilia
Reggio Emilia, Italy
RECRUITINGprogression free survival (PFS)
To evaluate the preliminary efficacy in terms of 12 months progression free survival (PFS) of durvalumab in association with carboplatin or cisplatin and etoposide in first line patients affected by extensive stage EPSCC. PFS isdefined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. According to the results of the CASPIAN trial \[18\] in which was observed a 12-month progression-free survival rates of 5% (2.4-8.0) for patients that had received Platinum-etoposide, it is expected to detect an increasing of at least 10 percentage points (to 15%).
Time frame: 12 months
Objective Response Rate (ORR)
Activity of durvalumab in combination with carboplatin or cisplatin plus etoposide in patients with untreated extensive- stage extrapulmonary small cell lung cancer (EPSCC). Activity will be measured as Objective Response Rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.
Time frame: 12 months
Disease control rate (DCR)
Disease control rate (DCR) measured as the percentage of patientswho have archived CR, PR, and stable disease (SD).
Time frame: 12 months
Overall survival (OS)
Overall survival (OS), defined as the time from initiation of study treatment to death from any cause.
Time frame: 24 months
Duration of response (DOR)
Duration of response (DOR), is 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: 12 months
quality of life (QoL)
To describe change in quality of life of patients during the study, measured as pre-defined PRO endpoints in this study are mean change from baseline in questionnaire administred at the enrollment time (baseline) and after the induction phase (3 +/- 2 weeks)
Time frame: 24 months
incidence, nature, frequency, and severity of Adverse Events (AEs)
Safety profile of durvalumab, defined in terms of incidence, nature, frequency, and severity of Adverse Events (AEs) and laboratory abnormalities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0;
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.