66
Participants
Start Date
January 16, 2024
Primary Completion Date
January 1, 2028
Study Completion Date
January 1, 2028
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."
RECRUITING
AUSL-IRCCS of Reggio Emilia, Reggio Emilia
Gruppo Oncologico Italiano di Ricerca Clinica
OTHER