NCT06246110 A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
| NCT ID | NCT06246110 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eikon Therapeutics |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-02-06 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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 recei