RecruitingPhase 2NCT06246110
A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
Sponsor
Eikon Therapeutics
Enrollment
70 participants
Start Date
Feb 6, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- be ≥ 18 years of age on the day of signing of informed consent.
- confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
- have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
- have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
- have not received prior systemic treatment for advanced/metastatic NSCLC.
- have an ECOG Performance Status of 0 to 1.
- have adequate organ function.
Exclusion Criteria6
- 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.
- 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.
- 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).
- has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
- 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.
- has an active infection requiring therapy.
Interventions
DRUGEIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
DRUGPembrolizumab
PD-1 inhibitor
DRUGPaclitaxel
Chemotherapy
DRUGPemetrexed
Chemotherapy
DRUGCarboplatin
Chemotherapy
Locations(39)
View Full Details on ClinicalTrials.gov
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NCT06246110
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