Study of EIK1001 with Pembrolizumab and Chemotherapy for Stage 4 NSCLC
This study is looking at a new drug, EIK1001, in combination with pembrolizumab (KEYTRUDA®) and standard chemotherapy for people with Stage 4 non-small cell lung cancer (NSCLC). EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist, which means it works by stimulating certain parts of your immune system. Researchers want to see if this combination is safe and effective. The study aims to enroll about 750 participants who are at least 18 years old, have a life expectancy of at least 3 months, and are candidates for standard treatment with pembrolizumab and chemotherapy. Success will be measured by how long participants live without their cancer getting worse (progression-free survival), how long they live overall (overall survival), and if their tumors shrink (objective response). The current recruitment status is unclear.
- Study design
- This is a global, multi-center, double-blind (meaning neither you nor your doctor will know if you're receiving the study drug or a placebo), placebo-controlled, randomized study. It will involve about 750 participants and has two phases (Phase 2 and Phase 3).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for progression-free survival and objective response for up to 6 years, and for overall survival for up to 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
At a glance
Conditions
Where it's being run
18 sites across 11 statesStudy leadership
- Nishitha Reddy · STUDY_DIRECTOR · Eikon Therapeutics
Who to contact
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What this trial measures
- Progression-free survival (PFS)Through study completion, up to 6 years
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
- Overall survival (OS)Through study completion, up to 10 years
OS defined as the time from the first dose of study medication to death due to any cause
- Objective Response (OR)Through study completion, up to 6 years
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).