A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients with Extensive Stage Small Cell Lung Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
The primary objective of the phase 1a portion of this study is to evaluate the safety profile and subject tolerability of rovalpituzumab tesirine (Rova-T) when administered as a single agent and in combination with standard chemotherapy.The primary objective of the phase 1b portion of this study is to evaluate the efficacy and long term safety of Rova-T when administered as a single agent and in combination with standard chemotherapy.Secondary objectives for both phases include to assess the anti-tumor activity of treatment with Rova-T when administered as monotherapy, in series, or in combination with frontline chemotherapy, characterize a safety profile for Rova-T and assess pharmacokinetics of Rova-T.
Subjects (over the age of 18) with histologically confirmed DLL3+ extensive-stage small cell lung cancer, who have only received one cycle of standard chemotherapy, in good physical condition with good blood counts and good organ function. Subjects are required to have measurable disease.
This is a two phase study. Phase 1a will include 4 treatment cohorts and focus on dose escalation. Phase 1b will involve one or two cohorts from phase 1a and focus on long term safety and efficacy. Each cycle of Rova-T (in both phases) will be 6 weeks (42 days) and each cycle of standard therapy (Cisplatin or carboplatin and Etoposide) will be 3 weeks (21 days).Upon successful completion of the screening process, including a laboratory confirmation of DLL3 expression, the subject will enroll in the current phase of the study. In phase 1a, subjects will be randomized into one of four treatment cohorts. Cohort 1 will receive Rova-T alone, Cohort 2 will receive 2 cycles of Rova-T followed by 4 cycles of standard therapy (with Cisplatin or carboplatin and Etoposide), Cohort 3 will receive 2 Cycles of Rova-T and 4 Cycles of standard therapy concurrently, and Cohort 4 will receive 4 cycles of standard therapy followed by 2 cycles of Rova-T. Subjects may be eligible for retreatment if they have progressed at least 12 weeks after their last dose of Rova-T or at least 4 weeks after their last dose of cisplatin or etoposide, whichever is later. In Phase 1b, up to 30 patients will be enrolled on whichever regimens from Phase 1a were the most effective. If only one treatment regimen was chosen, all subjects will receive that regimen. If two regimens are chosen, subjects in Phase 1b will be randomized to one of the two chosen treatment regimens.After the completion of the study treatment, subjects will be seen every 6 weeks until 6 months, then every 12 weeks.
03/05/2019 05:03 AM