Not Yet RecruitingPhase 2/3

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

750 participantsStarted 2026-05-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant must be ≥ 18 years old at the time of signing the informed consent.
✓. Participant has a life expectancy of at least 3 months.
✓. 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.
✓. 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.
✓. 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.
✓. Participant has not received prior systemic therapy for advanced/metastatic NSCLC.
✓. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
✓. 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).

Exclusion criteria

✕. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
✕. 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.
✕. has had major surgery (\< 3 weeks prior to the first dose of study intervention administration).
✕. has received a live-virus vaccination within 30 days of the start of study intervention initiation.
✕. has received radiation therapy within 7 days of the first dose of study intervention administration.
✕. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.

What they're measuring

Progression-free survival (PFS)

Timeframe: Through study completion, up to 6 years

Overall survival (OS)

Timeframe: Through study completion, up to 10 years

Objective Response (OR)

Timeframe: Through study completion, up to 6 years

Trial details

NCT IDNCT07365319

SponsorEikon Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2035-12-31

View on ClinicalTrials.gov More Non Small Cell Lung Cancer (Squamous or Non Squamous) trials