Phase 2 Study of EIK1001 with Pembrolizumab and Chemotherapy for Stage 4 Non-Small Cell Lung Cancer
Sponsor: Eikon Therapeutics
ClinicalTrials ID:NCT06246110
This clinical trial is for patients with advanced non-small cell lung cancer (NSCLC) who have not yet received treatment through an IV for their advanced condition. The study aims to test the safety and effectiveness of a new drug, EIK1001, in combination with standard treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing a new treatment combination for patients with stage 4 non-small cell lung cancer (NSCLC) who have not received any previous IV treatment for their advanced cancer. The trial will evaluate how safe and effective the drug EIK1001 is when used with standard care treatments, including chemotherapy and pembrolizumab. The study will also look at the best dose to use and any side effects that may occur.
Description
This is a phase 2 clinical trial conducted at multiple centers. It is open-label, meaning both the researchers and participants know what treatment is being given. The trial is designed to assess the safety, tolerability, and effectiveness of the drug EIK1001 when combined with standard treatments for patients with stage 4 non-small cell lung cancer (NSCLC). This includes both squamous and non-squamous types of NSCLC. Participants in the study have not received any previous systemic treatment for their advanced cancer. The study will involve finding the right dose of EIK1001 and monitoring for any side effects or adverse events, as well as evaluating how well the treatment works.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of stage 4 non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
- Must not have any mutations or fusions in the tumor that would require a different first-line treatment.
- Have at least one tumor that can be measured by scans.
- Have not received any previous systemic treatment for advanced or metastatic NSCLC.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by specific medical tests.
Exclusion Criteria
- Do not have predominantly squamous or non-squamous NSCLC. Mixed tumors with small cell elements are not eligible.
- Are currently in another clinical trial or have been in one within the last 4 weeks or 5 half-lives of the investigational drug.
- Have received any previous systemic therapy for metastatic disease or had major surgery within 3 weeks before starting the study.
- Have completed palliative radiotherapy within 7 days before starting the study treatment.
- Have a history of another cancer unless it was treated and has not recurred for at least 5 years.
- Have an active infection that requires treatment.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.