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.
This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
750
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
Time frame: Through study completion, up to 6 years
Overall survival (OS)
OS defined as the time from the first dose of study medication to death due to any cause
Time frame: Through study completion, up to 10 years
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).
Time frame: Through study completion, up to 6 years
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
Time frame: Up to 6 years
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.
Time frame: Up to 6 years
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.
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SOC Chemotherapy for squamous NSCLC
SOC Chemotherapy for squamous NSCLC
SOC Chemotherapy for non-squamous NSCLC
Time frame: Up to 6 years
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.
Time frame: Up to 6 years
Duration of Response (DOR) by Investigator
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 Investigator.
Time frame: Up to 6 years
Incidence of Adverse Events (AEs)
Adverse Events (AEs) and discontinuation of study treatment due to any AE.
Time frame: Up to 2.5 years