A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer

Brief description of study

This study aims to see how well a new drug, EIK1001, works when given with pembrolizumab and certain chemotherapies in patients with Stage 4 lung cancer who haven't had other treatments. Patients will get EIK1001 through an IV once a week, and pembrolizumab every three weeks for up to 35 cycles.

There are two groups: one will get EIK1001 with pemetrexed and carboplatin, and the other with paclitaxel and carboplatin. At first, a small number of patients will get a low dose of EIK1001 to check for serious side effects. If it’s safe, more patients will get a higher dose.

The main goal is to see if the treatment has few side effects. The study will also look at how well the treatment works against the cancer, how long patients live without the cancer getting worse, and other important health markers. Patients will have regular scans to check their cancer and will be watched closely for side effects. The treatment will continue until the cancer worsens, side effects are too severe, or other reasons the study teams decides is good enough for patient withdrawal. After treatment ends, patients will be followed for at least 90 days to monitor their health.


Clinical Study Identifier: s24-00180
ClinicalTrials.gov Identifier: NCT06246110
Principal Investigator: Marissa Rybstein.
Other Investigators: Joshua K Sabari, Samantha VanMaanen, Elka R Travis, Jessica Wang, Elaine Shum, Salman Rafi Punekar, Sally Lau, Danny Perlaza, David Mendoza, Natalia Cherkassky, Vamsidhar Velcheti, Jeffrey G Schneider, Avital Benson, James Newman, Melissa L Martinez.


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