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.
Parallel
EIK1001
DrugEIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
Pembrolizumab (KEYTRUDA®)
DrugPD-1 inhibitor
Placebo
DrugPlacebo control
Paclitaxel + Carboplatin
DrugSOC Chemotherapy for squamous NSCLC
Nab-paclitaxel + Carboplatin
DrugSOC Chemotherapy for squamous NSCLC
Pemetrexed + Cisplatin /Carboplatin
DrugSOC Chemotherapy for non-squamous NSCLC
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
Overall survival (OS)
OS defined as the time from the first dose of study medication to death due to any cause
Objective Response (OR)
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Objective response (OR)
Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR
Duration of response (DOR)
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR.
Progression-free survival (PFS) by Investigator
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by Investigator, or death due to any cause, whichever occurs first.
Overall Response Rate (ORR) by Investigator
Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator.
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Eikon Therapeutics
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
