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).
Eikon Therapeutics
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
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
Locations (3)
- NYU Langone Hospital Long IslandMineola, New York
- NYU Langone Hospital ManhattanNew York, New York
- White Plains HospitalWhite Plains, New York