Non-small Cell Lung Cancer Clinical Trial
Official title:
A Multicenter, Open-Label Study of LYC-55716 in Combination With Pembrolizumab in Adult Subjects With Metastatic Non-Small Cell Lung Cancer
This is a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the combination for biologic and clinical activity in NSCLC.
Approximately 18 subjects across 5 US sites will be enrolled in the study.
Subjects will enter a screening period of up to 28 days, followed by continuous twice daily
administration of LYC-55716 in 28 day treatment cycles. Subjects will also be administered
pembrolizumab every 3 weeks as prescribed as standard of care by the Investigator in
accordance with the package insert.
The study will begin with a run-in cohort of 3 subjects to assess the safety and tolerability
of the LYC-55716/pembrolizumab combination. Subjects in the run-in cohort will be enrolled
singly at intervals of not less than 7 days in order to monitor for adverse reactions to the
combination. If no subjects in the run-in cohorts has a DLT, then the study may proceed to
the main cohort (15 subjects).
Subjects will receive combination treatment until clinically significant disease progression
or unacceptable toxicity, or up to a maximum of 24 months.
Primary Study Objectives:
Run-in Cohort
- Evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination
- Determine the dose of LYC-55716 that is adequately tolerated when used in combination
with pembrolizumab
Main Study Cohort
• Further evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination
Secondary Study Objectives:
Main Study Cohort
- Evaluate the cellular immune response in paired tumor biopsy samples
- Evaluate effects on circulating biomarkers in the blood of LYC-55716 with pembrolizumab
- Determine the objective response rate
- Determine the duration of response
- Determine the progression-free survival (PFS) and overall survival (OS)
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