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Combining EIK1001 with Pembrolizumab and chemotherapy for advanced lung cancer

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer

Phase 2 Interventional Eikon Therapeutics · NCT06246110

This study is testing a new treatment combining EIK1001 with chemotherapy and Pembrolizumab to see if it helps people with advanced lung cancer who haven't had treatment before.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment70 (estimated)
Ages18 Years and up
SexAll
SponsorEikon Therapeutics Industry-sponsored
Locations39 sites (Daphne, Alabama and 38 other locations)
Trial IDNCT06246110 on ClinicalTrials.gov

What this trial studies

This multicenter open-label phase 2 trial evaluates the safety, tolerability, and efficacy of EIK1001 in combination with standard chemotherapy and Pembrolizumab in patients with stage 4 non-small cell lung cancer (NSCLC) who have not received prior systemic treatment. The study focuses on both squamous and non-squamous types of NSCLC and includes dose-finding assessments along with monitoring for adverse events and treatment efficacy. Participants will be closely monitored to determine the effectiveness of this combination therapy in managing their advanced disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed stage 4 NSCLC who have not received prior systemic therapy.

Not a fit: Patients with mixed histology tumors or those who have received prior systemic treatment for advanced NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced NSCLC who have limited treatment alternatives.

How similar studies have performed: While this approach is being explored in this specific combination, similar studies have shown promise in treating advanced NSCLC with immunotherapy and chemotherapy.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Daphne, Alabama and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NSCLCSquamousNonsquamousMetastatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.