Active Not RecruitingPhase 2NCT06246110

A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.

Checked against the public recordLast updated May 28, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 2
U.S. locations38
SponsorEikon Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eikon Therapeutics
Interventions being studied
Drug: EIK1001; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin
02
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

Inclusion Criteria: 1. be ≥ 18 years of age on the day of signing of informed consent. 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care. 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy). 4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment. 5. have not received prior systemic treatment for advanced/metastatic NSCLC. 6. have an ECOG Performance Status of 0 to 1. 7. have adequate organ function. Exclusion Criteria: 1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001. 3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose). 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration. 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years. 6. has an active infection requiring therapy.

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

04
Study sites

U.S. locations

  • Southern Cancer CareDaphne, Alabama
  • Ironwood Cancer and Research CenterChandler, Arizona
  • California Cancer Care Associates for Research & ExcellenceFresno, California
  • California Research InstituteLos Angeles, California
  • University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, California
  • Providence St Joseph Hospital, Center for Cancer Prevention and TreatmentOrange, California
  • Sutter Health Institute for Medical ResearchSacramento, California
  • Rocky Mountain CancerLone Tree, Colorado
  • Bioresearch PartnerHialeah, Florida
  • Memorial Cancer InstituteHollywood, Florida
  • Mid-Florida Hematology and Oncology CenterOrange, Florida
  • Orlando Health Cancer InstituteOrlando, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 28, 2026. Always confirm current availability with the study team.

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