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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.