Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer
The duration of the study for a patient will include a period for inclusion of up to 3
weeks. The patients may continue treatment up to a maximum of 6 cycles or until disease
progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day
follow-up after the last study treatment administration.
Patients will be followed for at least 30 days after the last administration of study
treatment for safety purpose. In case of study treatment discontinuation without disease
progression, efficacy data will be collected every 6 weeks until disease progression, death
or end of study whatever comes first. After disease progression, the patient will be
followed-up every 12 weeks (3 months) for overall survival (OS) until death or end of study
whatever comes first.
The end of the study will be one year after the first dose of the last treated patient.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate
up to a maximum follow-up of 25 weeks
Clinical Sciences & Operations
Italy: Ethics Committee