Active, currently enrolling
A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer
NCT No.: NCT06246110
Study Type: INTERVENTIONAL
Phase:
Phase II
Official Title
A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer
Purpose
The purpose of this clinical trial is to see how well the study drug, EIK1001, works in combination with the standard pembrolizumab – chemotherapy combination in treating Stage 4 NSCLC.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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1. be = 18 years of age on the day of signing of informed consent. 2. have a life expectancy of at least 3 months. 3. have histologically or cytologically confirmed Stage 4 NSCLC (squamous or nonsquamous) and be considered for standard therapy with pembrolizumab and chemotherapy. 4. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy). 5. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
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Exclusion Criteria
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1. does not have predominantly squamous cell or nonsquamous 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. Note: Participants cannot have received prior therapy for NSCLC (see Inclusion Criteria #6). 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 received a live-virus vaccination within 30 days of the start of treatment initiation. 5. has received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study drug administration.
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Keywords and/or Specific Medical Conditions
Sponsors
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