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).
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).
Arms & interventions
- DrugEIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
- DrugPembrolizumab (KEYTRUDA®)
PD-1 inhibitor
- DrugPlacebo
Placebo control
- DrugPaclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
- DrugNab-paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
- DrugPemetrexed + Cisplatin /Carboplatin
SOC Chemotherapy for non-squamous NSCLC
Outcome measures
Primary
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
Time frame: Through study completion, up to 6 years
Overall survival (OS)
OS defined as the time from the first dose of study medication to death due to any cause
Time frame: Through study completion, up to 10 years
Objective Response (OR)
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Time frame: Through study completion, up to 6 years
Secondary
Objective response (OR)
Time frame: Up to 6 years
Duration of response (DOR)
Time frame: Up to 6 years
Progression-free survival (PFS) by Investigator
Time frame: Up to 6 years
Overall Response Rate (ORR) by Investigator
Time frame: Up to 6 years
Duration of Response (DOR) by Investigator
Time frame: Up to 6 years
Incidence of Adverse Events (AEs)
Time frame: Up to 2.5 years
Eligibility criteria
Study locations (3)
NYU Langone Hospital Long Island
Mineola, New York, 11501
NYU Langone Hospital Manhattan
New York, New York, 10016
White Plains Hospital
White Plains, New York, 10601