Perlmutter Cancer Center

This Phase 2/3 study is testing whether adding EIK1001 (investigational drug) to the combination of pembrolizumab and chemotherapy is more effective in treating patients with stage 4 non-small cell lung cancer (NSCLC) compared to using pembrolizumab + chemotherapy alone. Participants with non-squamous NSCLC will receive EIK1001 combined with pembrolizumab and pemetrexed plus either carboplatin or cisplatin chemotherapy. Those with squamous NSCLC will receive EIK1001 combined with pembrolizumab and chemotherapy using carboplatin plus either paclitaxel or nab-paclitaxel. The main goals are to see if this combination helps delay the growth of the cancer and improves the survival of patients.

In this study, neither the participants nor the researchers know who is receiving the treatment or the placebo (inactive treatment). Participants are randomly assigned to either the treatment or placebo group. The study is divided into two parts: one to find the best dose (dose optimization) and another to expand treatment (dose expansion), with patients needing to have measurable tumors and no specific genetic mutations that would make them eligible for other treatments. In dose optimization, participants will be randomly assigned to one of three groups: Arm 1, Arm 2 or Arm 3. Participants in Arm 1 will receive a placebo along with pembrolizumab and the chemotherapy that’s right for their tumor type. In Arm 2, participants will receive EIK1001 (0.45 mg/m²) every week for the first 24 weeks, then every 3 weeks, plus pembrolizumab and the right chemotherapy for their tumor. Participants in Arm 3 will receive EIK1001 (0.60 mg/m²) every week for the first 24 weeks, then every 3 weeks, plus pembrolizumab and the right chemotherapy for their tumor. In the dose expansion part of the study, participants will be split into two groups: ongoing participants or new participants. The ongoing participants will either stay on the placebo plus pembrolizumab and chemotherapy, or on the EIK1001 selected dose (either 0.45 mg/m² or 0.60 mg/m²) plus pembrolizumab and chemotherapy. The new participants will be randomly assigned to one of two groups and will receive either placebo plus pembrolizumab and chemotherapy (arm 1) or EIK1001 (selected dose) plus pembrolizumab and chemotherapy (arm 2). Interim analyses (IAs) will be done during the study to decide if it should move from Phase 2 to Phase 3. Phase 3 part of the study will include participants who are continuing from Phase 2, as well as new participants. The new participants will be randomly assigned to one of two groups: one will receive the selected dose of EIK1001 plus pembrolizumab and chemotherapy, and the other will receive placebo plus pembrolizumab and chemotherapy (chosen by the doctor based on the tumor type).

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicines. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.