RecruitingRecruiting
A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
NCT07365319 · Eikon Therapeutics
In plain English
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Official title
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
About this study
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
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.
Study design
Enrollment target: 750 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-06-15
Estimated completion: 2040-12-31
Last updated: 2026-07-15
Interventions
Drug: EIK1001Drug: Pembrolizumab (KEYTRUDA®)Drug: PlaceboDrug: Paclitaxel + CarboplatinDrug: Nab-paclitaxel + CarboplatinDrug: Pemetrexed + Cisplatin /Carboplatin
Primary outcomes
- • Progression-free survival (PFS) (Through study completion, up to 6 years)
- • Overall survival (OS) (Through study completion, up to 10 years)
- • Objective Response (OR) (Through study completion, up to 6 years)
Sponsor
Eikon Therapeutics · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactElelta Shiferraw · contact · shiferrawe@eikontx.com · 314-209-3659
InvestigatorNishitha Reddy · study_director, Eikon Therapeutics
All locations (10)
Southern Cancer Center, P.C.Recruiting
Daphne, Alabama, United States
Los Angeles Cancer NetworkRecruiting
Glendale, California, United States
Rocky Mountain Cancer Centers, LLPRecruiting
Pueblo, Colorado, United States
NYU Langone Hospital Long IslandRecruiting
Mineola, New York, United States
NYU Langone Hospital ManhattanRecruiting
New York, New York, United States
White Plains HospitalRecruiting
White Plains, New York, United States
Blue Ridge Cancer CenterRecruiting
Blacksburg, Virginia, United States
Virginia Cancer Specialists, PCRecruiting
Fairfax, Virginia, United States
Shenandoah Oncology P.C.Recruiting
Winchester, Virginia, United States
Institut Catala D'Oncologia de GironaRecruiting
Girona, Spain