A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

Launched by EIKON THERAPEUTICS · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EIK1001, which is being tested in combination with pembrolizumab (a type of immunotherapy) and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. The trial is looking for adults aged 18 and older who have not received any previous treatment for their advanced NSCLC and whose cancer does not have specific mutations that would require different therapy.

To be eligible for this study, participants must have confirmed Stage 4 NSCLC and at least one measurable tumor. They should also be in relatively good health, meaning they can carry out daily activities with minimal assistance. Throughout the trial, participants will receive the study treatment and will be monitored for its effects. This is an exciting opportunity for eligible patients to potentially benefit from a new combination therapy aimed at improving their cancer treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. be ≥ 18 years of age on the day of signing of informed consent.
• • 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
• • 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
• • 4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
• • 5. have not received prior systemic treatment for advanced/metastatic NSCLC.
• • 6. have an ECOG Performance Status of 0 to 1.
• • 7. have adequate organ function.
• Exclusion Criteria:
• • 1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
• • 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001.
• • 3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose).
• • 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
• • 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years.
• • 6. has an active infection requiring therapy.