A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

Running, not enrolling · Phase 2

Conditions studied: NSCLC

In brief

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.

Key facts

Study ID

NCT06246110

Run by

Eikon Therapeutics

People needed

70

Starts

2024-02-06

Expected to finish

2027-12-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southern Cancer Care — Daphne, Alabama, United States
• Ironwood Cancer and Research Center — Chandler, Arizona, United States
• California Cancer Care Associates for Research & Excellence — Fresno, California, United States
• California Research Institute — Los Angeles, California, United States
• University of Southern California, Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Providence St Joseph Hospital, Center for Cancer Prevention and Treatment — Orange, California, United States
• Sutter Health Institute for Medical Research — Sacramento, California, United States
• Rocky Mountain Cancer — Lone Tree, Colorado, United States
• Bioresearch Partner — Hialeah, Florida, United States
• Memorial Cancer Institute — Hollywood, Florida, United States
• Mid-Florida Hematology and Oncology Center — Orange, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Atlanta Piedmont Hospital — Atlanta, Georgia, United States
• Kaiser Permanente Hawaii — Honolulu, Hawaii, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Accelacare of Duly — Tinley Park, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Health Midwest Oncology Associates of Kansas — Overland Park, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Medstar Franklin Square Cancer Center at Loch Raven Campus — Baltimore, Maryland, United States
• Maryland Oncology — Columbia, Maryland, United States
• Jersey Shore University Medical Center/Meridian Hematology & Oncology — Neptune City, New Jersey, United States
• New York Cancer and Blood Specialists — Babylon, New York, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• Weil Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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