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
Providence St. Joseph Hospital
Orange, California 92868
United States
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado 81103
United States
Florida Clinical Trials Group
Plantation, Florida 33322
United States
Florida Clinical Trials Group - Tamarac
Tamarac, Florida 33321
United States
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United States
University of New Mexico - Comprehensive Cancer Center
Albuquerque, New Mexico 87102
United States
NYU Langone Hospital Long Island
Mineola, New York 11501
United States
NYU Langone Hospital Manhattan
New York, New York 10016
United States
Jacobi Medical Center - Albert Einstein College of Medicine
The Bronx, New York 10461
United States
White Plains Hospital
White Plains, New York 10601
United States
Tennessee Oncology
Nashville, Tennessee 37203
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
Cancer Care Northern Beaches
Frenchs Forest, New South Wales 2086
Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales 2298
Australia
Peninsula and Southeast Oncology (PASO) Medical
Frankston, Victoria 3199
Australia
Sunshine Hospital - Western Health
Saint Albans, Victoria 3021
Australia
Task Eden
George, Western Cape 6529
South Africa
Yeungnam University College of Medicine
Daegu, Daegu 42415
South Korea
Gachon University - Gil Medical Center
Incheon, Incheon Gwang'Yeogsi 21565
South Korea
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cadiz 11407
Spain
Consorci Hospitalari Provincial de Castello
Castellon, Castellón 12006
Spain
Instituto Oncologico Dr. Rosell (IOR)
Barcelona, 08028
Spain
Institut Catala D'Oncologia de Girona
Girona, 17007
Spain
Hospital Quirónsalud Málaga
Málaga, 29004
Spain