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

NCT07365319 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: EIK1001-0082025-525013-23-00KEYNOTE-G57MK-3475-G57
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer (Squamous or Non Squamous); Stage 4 NSCLC

Keywords

Non Small Cell Lung Cancer; EIK1001

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Objective response (OR)

  Up to 6 years

• Duration of response (DOR)

  Up to 6 years

• Progression-free survival (PFS) by Investigator

  Up to 6 years

• Overall Response Rate (ORR) by Investigator

  Up to 6 years

• Duration of Response (DOR) by Investigator

  Up to 6 years

Study Arms (3)

Arm 1 (Placebo in Combination with SOC)

PLACEBO COMPARATOR

Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).

Drug: Pembrolizumab (KEYTRUDA®); Drug: Placebo; Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin

Arm 2 (EIK1001 in Combination with SOC)

EXPERIMENTAL

Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).

Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA®); Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin

Arm 3 (EIK1001 in Combination with SOC)

EXPERIMENTAL

Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).

Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA®); Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin

Interventions

EIK1001 DRUG

EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist

Arm 2 (EIK1001 in Combination with SOC); Arm 3 (EIK1001 in Combination with SOC)

Pembrolizumab (KEYTRUDA®) DRUG

PD-1 inhibitor

Arm 1 (Placebo in Combination with SOC); Arm 2 (EIK1001 in Combination with SOC); Arm 3 (EIK1001 in Combination with SOC)

Placebo DRUG

Placebo control

Arm 1 (Placebo in Combination with SOC)

Paclitaxel + Carboplatin DRUG

SOC Chemotherapy for squamous NSCLC

Arm 1 (Placebo in Combination with SOC); Arm 2 (EIK1001 in Combination with SOC); Arm 3 (EIK1001 in Combination with SOC)

Nab-paclitaxel + Carboplatin DRUG

SOC Chemotherapy for squamous NSCLC

Arm 1 (Placebo in Combination with SOC); Arm 2 (EIK1001 in Combination with SOC); Arm 3 (EIK1001 in Combination with SOC)

Pemetrexed + Cisplatin /Carboplatin DRUG

SOC Chemotherapy for non-squamous NSCLC

Arm 1 (Placebo in Combination with SOC); Arm 2 (EIK1001 in Combination with SOC); Arm 3 (EIK1001 in Combination with SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eikon Therapeutics: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; CP protocol; 130-nm albumin-bound paclitaxel; Carboplatin; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Etah Kurland, MD

  Eikon Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 26, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2040
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share