AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA

PHASE2RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 16, 2024

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2028

Conditions
Extrapulmonary Small Cell Carcinoma
Interventions
DRUG

Durvalumab

"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."

Trial Locations (1)

42123

RECRUITING

AUSL-IRCCS of Reggio Emilia, Reggio Emilia

All Listed Sponsors
lead

Gruppo Oncologico Italiano di Ricerca Clinica

OTHER