This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
Participant must be ≥ 18 years old at the time of signing the informed consent.
Participant has a life expectancy of at least 3 months.
Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
has received a live-virus vaccination within 30 days of the start of study intervention initiation.
Eikon Therapeutics
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator