RecruitingPhase 2 / Phase 3NCT07365319

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

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.

Checked against the public recordLast updated Aug 19, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 2 / Phase 3
U.S. locations18
SponsorEikon Therapeutics
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
Eikon Therapeutics
Interventions being studied
Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA®); Drug: Placebo; Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Southern Cancer Center, P.C.Daphne, Alabama
  • Los Angeles Cancer NetworkGlendale, California
  • Providence St. Joseph HospitalOrange, California
  • Rocky Mountain Cancer Centers, LLPPueblo, Colorado
  • OSF Saint Francis Medical CenterPeoria, Illinois
  • University of New Mexico - Comprehensive Cancer CenterAlbuquerque, New Mexico
  • NYU Langone Hospital Long IslandMineola, New York
  • NYU Langone Hospital ManhattanNew York, New York
  • Jacobi Medical Center - Albert Einstein College of MedicineThe Bronx, New York
  • White Plains HospitalWhite Plains, New York
  • Blue Ridge Cancer CenterBlacksburg, Virginia
  • Virginia Cancer Specialists, PCFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 19, 2026. Always confirm current availability with the study team.

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