A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.

Official title

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).

Overview

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.

Detailed description

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).

Interventions

• Drug EIK1001
  EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
• Drug Pembrolizumab (KEYTRUDA®)
  PD-1 inhibitor
• Drug Placebo
  Placebo control
• Drug Paclitaxel + Carboplatin
  SOC Chemotherapy for squamous NSCLC
• Drug Nab-paclitaxel + Carboplatin
  SOC Chemotherapy for squamous NSCLC
• Drug Pemetrexed + Cisplatin /Carboplatin
  SOC Chemotherapy for non-squamous NSCLC

Primary outcome measures

• Progression-free survival (PFS) [Time frame: Through study completion, up to 6 years]
• Overall survival (OS) [Time frame: Through study completion, up to 10 years]
• Objective Response (OR) [Time frame: Through study completion, up to 6 years]

Secondary outcome measures (6)

• Objective response (OR) [Time frame: Up to 6 years]
• Duration of response (DOR) [Time frame: Up to 6 years]
• Progression-free survival (PFS) by Investigator [Time frame: Up to 6 years]
• Overall Response Rate (ORR) by Investigator [Time frame: Up to 6 years]
• Duration of Response (DOR) by Investigator [Time frame: Up to 6 years]
• Incidence of Adverse Events (AEs) [Time frame: Up to 2.5 years]

Eligibility criteria

Inclusion criteria

• 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.
• Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
• Participant has not received prior systemic therapy for advanced/metastatic NSCLC.

Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.

• Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
• Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is < 3yrs old).

Exclusion criteria

• 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.
• has received radiation therapy within 7 days of the first dose of study intervention administration.
• has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 12 centers

• Southern Cancer Center, P.C. — Daphne
• Los Angeles Cancer Network — Glendale
• Providence St. Joseph Hospital — Orange
• Rocky Mountain Cancer Centers, LLP — Pueblo
• University of New Mexico - Comprehensive Cancer Center — Albuquerque
• NYU Langone Hospital Long Island — Mineola
• NYU Langone Hospital Manhattan — New York
• Jacobi Medical Center - Albert Einstein College of Medicine — The Bronx
• … and 4 more centers

Spain · 2 centers

• Hospital Universitario de Jerez de la Frontera — Jerez de la Frontera
• Institut Catala D'Oncologia de Girona — Girona

Identifiers

NCT: NCT07365319 · EIK1001-008 · 2025-525013-23-00 · KEYNOTE-G57 · MK-3475-G57

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗