Study on EIK1001 with Pembrolizumab and Chemotherapy for Stage 4 Non-Small Cell Lung Cancer
Sponsor: Eikon Therapeutics
ClinicalTrials ID:NCT07365319
This clinical trial is testing a new treatment combination of EIK1001, pembrolizumab, and chemotherapy to see if it is safe and effective for patients with Stage 4 Non-Small Cell Lung Cancer (NSCLC).
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a new drug, EIK1001, when used together with pembrolizumab and chemotherapy in patients with Stage 4 Non-Small Cell Lung Cancer (NSCLC). The treatment is given through an IV and is being tested in patients who have not received previous systemic therapy for their advanced cancer.
Description
This global study is being conducted in multiple centers and involves two phases (Phase 2 and Phase 3). It is a double-blind, placebo-controlled, randomized study, meaning neither the participants nor the researchers know who is receiving the actual treatment or a placebo. The study is divided into three parts: optimizing the dose, expanding the dose, and confirming the treatment's effectiveness. Participants with Stage 4 NSCLC, either squamous or non-squamous, will receive EIK1001 along with pembrolizumab and chemotherapy drugs like pemetrexed with carboplatin or cisplatin for non-squamous NSCLC, or carboplatin with paclitaxel or nab-paclitaxel for squamous NSCLC.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a life expectancy of at least 3 months.
- Have confirmed Stage 4 NSCLC, either squamous or non-squamous, and be eligible for standard treatment with pembrolizumab and chemotherapy.
- Must not have mutations or fusions that require specific targeted therapies.
- Have at least one measurable tumor.
- Have not received prior systemic therapy for advanced NSCLC, except if previous treatment was more than a year ago.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have tumor tissue available for PD-L1 testing from a non-radiated site.
Exclusion Criteria
- Have small cell lung cancer or tumors that are not predominantly non-squamous or squamous NSCLC.
- Are currently in another study or have recently received an investigational treatment.
- Have had major surgery within the last 3 weeks.
- Have received a live-virus vaccine within 30 days before starting the study.
- Have had radiation therapy within 7 days before starting the study.
- Have completed palliative radiotherapy within 7 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NYU Langone Hospital Long Island | 11501 | Mineola | New York |
| NYU Langone Hospital Manhattan | 10016 | New York | New York |
| White Plains Hospital | 10601 | White Plains | New York |
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