A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
Purpose
This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.
Condition
- NSCLC
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A - Participants with non-squamous NSCLC |
Participants in this arm will receive EIK1001 + Standard of Care (SOC). |
|
|
Experimental Cohort B - Participants with squamous NSCLC |
Participants in this arm will receive EIK1001 + Standard of Care (SOC). |
|
Recruiting Locations
Medstar Franklin Square Cancer Center at Loch Raven Campus
Baltimore, Maryland 21237
Baltimore, Maryland 21237
More Details
- Status
- Recruiting
- Sponsor
- Eikon Therapeutics
Detailed Description
This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.