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

Inclusion 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 ofcare.

3. have confirmation that mutation-directed therapy is not indicated (documentation ofabsence of tumor activating mutations/fusions that are approved for first linetherapy).

4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1as 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.

Exclusion Criteria:

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 cellelements are present, the participant is ineligible.

2. is currently participating in or has participated in a study of an investigationalagent and received investigational therapy within 4 weeks or 5 half-lives (whicheveris shorter) of administration of EIK1001.

3. prior to the first dose of EIK1001, has received prior systemic therapy formetastatic 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 drugadministration.

5. has a known history of prior malignancy, except if the participant has undergonepotentially curative therapy with no evidence of that disease recurrence for 5years.

6. has an active infection requiring therapy.