Induction phase of carboplatin+etoposide+pembrolizumab followed by maintenance of Pembrolizumab+sacituzumab govitecan
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of ES SCLC will be enrolled in this study.
The participant has not been previously treated with systemic therapy for ES SCLC (i.e., the disease is treatment naïve).
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received prior systemic anti-cancer therapy including biologic agents or investigational agents or an investigational device within 4 weeks prior to treatment initiation.
Has received prior radiotherapy, chemotherapy, or targeted small molecule therapy within 2 weeks of start of study intervention and have not recovered from AEs at the time of study entry (i.e., ≥Grade 2 is considered not recovered), or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Have not recovered (i.e., ≥Grade 2 is considered not recovered) from AEs due to a previously administered agent.
Nir Peled
Lead sponsor
Shaare Zedek Medical Center
Sponsor institution