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NCT07365319PHASE2, PHASE3Recruiting

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

Eikon Therapeutics

Start Date

6/15/2026

Completion Date

12/31/2040

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.

Detailed Description

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

EIK1001

DRUG

Pembrolizumab (KEYTRUDA®)

DRUG

Placebo

DRUG

Paclitaxel + Carboplatin

DRUG

Nab-paclitaxel + Carboplatin

DRUG

Pemetrexed + Cisplatin /Carboplatin

Interested in This Trial?

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Conditions

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

Locations

Southern Cancer Center, P.C.

Daphne, Alabama 36526

United States

Los Angeles Cancer Network

Glendale, California 91204

United States

Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado 81103

United States

NYU Langone Hospital Long Island

Mineola, New York 11501

United States

NYU Langone Hospital Manhattan

New York, New York 10016

United States

White Plains Hospital

White Plains, New York 10601

United States

Blue Ridge Cancer Center

Blacksburg, Virginia 24060

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Shenandoah Oncology P.C.

Winchester, Virginia 22601

United States

Institut Catala D'Oncologia de Girona

Girona, 17007

Spain