A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

Conditions

Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)

Brief summary

1. PFS defined as the time from randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first., 2. OS defined as the time from randomization to death due to any cause Objective Response (OR; defined as participants who demonstrate CR or PR by RECIST 1.1 as assessed by the Investigator), AEs, and discontinuation of study intervention due to an AE (Dose Optimization Only)

Detailed description

1. Objective Response (OR) defined as participants who demonstrate confirmed CR or PR according to RECIST 1.1 by BICR, 2. DOR defined as the time from the first document edevidence of CR or PR until disease progression or death due to any cause, whichever occurs first, according to RECIST 1.1 by BICR, 3. PFS, OR, and DOR according to RECIST 1.1 by Investigator, 4. AEs and discontinuation of study intervention due to any AE

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Interventions

DRUGPEMBROLIZUMAB

DRUGEIK1001 solution for injection 1.0 mg/mL free base equivalent

DRUGInactive control which is identical in appearance and composition as EIK1001 drug product except for the lack of EIK1001 drug substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. PFS defined as the time from randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first., 2. OS defined as the time from randomization to death due to any cause Objective Response (OR; defined as participants who demonstrate CR or PR by RECIST 1.1 as assessed by the Investigator), AEs, and discontinuation of study intervention due to an AE (Dose Optimization Only)	—

Measure

Time frame