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A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
750 patients around the world
Available in Belgium, Spain, Brazil, United States
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).
Eikon Therapeutics
3Research sites
750Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.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.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).
- 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.
Sites
HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM
Recruiting
Núcleo de Oncologia da Bahia
Recruiting
Oncoclínicas
Recruiting
StudyTeLuRide-008
SponsorEikon Therapeutics
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07365319
