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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Pembrolizumab; Drug: EIK1001

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Daphne, Alabama, United States, 36608
      • Southern Cancer Care
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer and Research Center
  • California
    • Fresno, California, United States, 93720
      • California Cancer Care Associates for Research & Excellence
    • Los Angeles, California, United States, 90033
      • University of Southern California, Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90027
      • California Research Institute
    • Orange, California, United States, 92868
      • Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
    • Sacramento, California, United States, 95816
      • Sutter Health Institute for Medical Research
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer
  • Florida
    • Hialeah, Florida, United States, 33013
      • BioResearch Partner
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute
    • Orange, Florida, United States, 32763
      • Mid-Florida Hematology and Oncology Center
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Piedmont Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Hawaii
  • Illinois
    • Niles, Illinois, United States, 60714
      • Illinois Cancer Specialists
    • Tinley Park, Illinois, United States, 60487
      • Accelacare of Duly
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Cancer Center
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Health Midwest Oncology Associates of Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Medstar Franklin Square Cancer Center at Loch Raven Campus
    • Columbia, Maryland, United States, 20144
      • Maryland Oncology
  • New Jersey
    • Neptune City, New Jersey, United States, 07753
      • Jersey Shore University Medical Center/Meridian Hematology & Oncology
  • New York
    • Babylon, New York, United States, 11702
      • New York Cancer and Blood Specialists
    • New York, New York, United States, 10016
      • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
    • New York, New York, United States, 10022
      • Weil Cornell Medical Center
    • The Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine, Jacobi Medical Center
    • White Plains, New York, United States, 10601
      • Cancer and Blood Specialists of New York, White Plains Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Messino Cancer Centers
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology, Austin
    • Bedford, Texas, United States, 76022
      • Texas Oncology, Bedford
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Blue Ridge Cancer Care Oncology Associates SW VA
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
    • Winchester, Virginia, United States, 22601
      • Shenandoah Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001.
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 completed palliative radiotherapy within 7 days of the first dose of study drug administration.
5. 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.
6. has an active infection requiring therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A - Participants with non-squamous NSCLC; Participants in this arm will receive EIK1001 + Standard of Care (SOC).	Drug: Pemetrexed; Chemotherapy; Drug: Carboplatin; Chemotherapy; Drug: Pembrolizumab; PD-1 inhibitor; Drug: EIK1001; EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
Experimental: Cohort B - Participants with squamous NSCLC; Participants in this arm will receive EIK1001 + Standard of Care (SOC).	Drug: Paclitaxel; Chemotherapy; Drug: Carboplatin; Chemotherapy; Drug: Pembrolizumab; PD-1 inhibitor; Drug: EIK1001; EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with safety event during treatment	Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with objective response rate (ORR) and duration of response (DOR).	Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) by RECIST 1.1 and DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, as assessed by the investigator.	Up to 4 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) at Final Follow-Up	OS defined as the time from the first dose of study medication to death due to any cause	Up to 4 years
Progression Free Survival (PFS)	Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression by RECIST 1.1 (Investigator) or death due to any cause, whichever occurs first	Up to 4 years

Collaborators and Investigators

• Sponsor: Eikon Therapeutics
• Investigators: Study Director: Etah Kurland, MD, Eikon Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic; Squamous; Nonsquamous
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Pemetrexed; Carboplatin; Paclitaxel; pembrolizumab
• Other Study ID Numbers: EIK1001-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No