EIK1001 with pembrolizumab and chemotherapy in stage 4 non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 trial evaluating intravenous EIK1001 in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed with carboplatin or cisplatin for non-squamous NSCLC; paclitaxel or nab-paclitaxel with carboplatin for squamous NSCLC). The study aims to determine clinical activity and safety across dose-optimization, dose-expansion, and confirmatory testing segments. Eligible participants are adults with untreated stage 4 NSCLC who lack targetable mutations and have measurable disease by RECIST 1.1. The trial is conducted at multiple sites under a collaborative sponsorship from Eikon Therapeutics with Merck Sharp & Dohme LLC.

Why it matters

Who can join: the full rules

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.

Where it's running

• Southern Cancer Center, P.C.
  Daphne, Alabama, United States Recruiting
• Los Angeles Cancer Network
  Glendale, California, United States Recruiting
• Providence St. Joseph Hospital
  Orange, California, United States Recruiting
• Rocky Mountain Cancer Centers, LLP
  Pueblo, Colorado, United States Recruiting
• Omnicure Clinical Research
  Doral, Florida, United States Recruiting
• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting

Study contacts

• Study coordinator: Elelta Shiferraw
• Email: shiferrawe@eikontx.com
• Phone: 314-209-3659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.