A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

Eligibility Criteria

• 1. be ≥ 18 years of age on the day of signing of informed consent.
• 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
• 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
• 4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
• 5. have not received prior systemic treatment for advanced/metastatic NSCLC.
• 6. have an ECOG Performance Status of 0 to 1.
• 7. have adequate organ function.
• 1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
• 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001.
• 3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose).
• 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
• 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years.
• 6. has an active infection requiring therapy.