A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer. (TeLuRide-008)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer (Squamous or Non Squamous); Stage 4 NSCLC
• Intervention / Treatment: Drug: Placebo; Drug: Pembrolizumab (KEYTRUDA®); Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin; Drug: EIK1001

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).

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Elelta Shiferraw; Phone Number: 314-209-3659; Email: shiferrawe@eikontx.com

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Recruiting
      • NYU Langone Hospital Long Island
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Hospital Manhattan
    • White Plains, New York, United States, 10601
      • Recruiting
      • White Plains Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Participant must be ≥ 18 years old at the time of signing the informed consent.
2. Participant has a life expectancy of at least 3 months.
3. 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.
4. 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.
5. 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.

6. 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.

7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
8. 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).

Key Exclusion Criteria:

1. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
2. 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.
3. has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
4. has received a live-virus vaccination within 30 days of the start of study intervention initiation.
5. has received radiation therapy within 7 days of the first dose of study intervention administration.
6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1 (Placebo in Combination with SOC); Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).	Drug: Placebo; Placebo control; Drug: Pembrolizumab (KEYTRUDA®); PD-1 inhibitor; 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
Experimental: Arm 2 (EIK1001 in Combination with SOC); Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).	Drug: Pembrolizumab (KEYTRUDA®); PD-1 inhibitor; 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; Drug: EIK1001; EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
Experimental: Arm 3 (EIK1001 in Combination with SOC); Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).	Drug: Pembrolizumab (KEYTRUDA®); PD-1 inhibitor; 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; Drug: EIK1001; EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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).	Through study completion, up to 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	Up to 6 years
Incidence of Adverse Events (AEs)	Adverse Events (AEs) and discontinuation of study treatment due to any AE.	Up to 2.5 years

Collaborators and Investigators

• Sponsor: Eikon Therapeutics
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Nishitha Reddy, Eikon Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Non Small Cell Lung Cancer; EIK1001
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; pembrolizumab; 130-nm albumin-bound paclitaxel; CP protocol
• Other Study ID Numbers: EIK1001-008; 2025-525013-23-00 (Ctis); KEYNOTE-G57 (Other Identifier: Merck Sharp & Dohme LLC); MK-3475-G57 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No