A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
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
Interventions
EIK1001
Pembrolizumab (KEYTRUDA®)
Placebo
Paclitaxel + Carboplatin
Nab-paclitaxel + Carboplatin
Pemetrexed + Cisplatin /Carboplatin
Conditions
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