A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
Eikon Therapeutics
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 E…
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)
- Southern Cancer CareDaphne, Alabama
- Ironwood Cancer and Research CenterChandler, Arizona
- California Cancer Care Associates for Research & ExcellenceFresno, California
- California Research InstituteLos Angeles, California
- University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, California
- Providence St Joseph Hospital, Center for Cancer Prevention and TreatmentOrange, California