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A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT06246110
Recruitment Status : Recruiting
First Posted : February 7, 2024
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Eikon Therapeutics

Tracking Information
First Submitted Date  ICMJE January 30, 2024
First Posted Date  ICMJE February 7, 2024
Last Update Posted Date March 4, 2024
Actual Study Start Date  ICMJE February 6, 2024
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2024)		 Percentage of participants with safety event during treatment [ Time Frame: Up to 2 years ]
Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2024)		 Percentage of participants with objective response rate (ORR) and duration of response (DOR). [ Time Frame: Up to 4 years ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2024)
  • Overall Survival (OS) at Final Follow-Up [ Time Frame: Up to 4 years ]
    OS defined as the time from the first dose of study medication to death due to any cause
  • Progression Free Survival (PFS) [ Time Frame: Up to 4 years ]
    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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE
  • Drug: EIK1001
    EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
  • Biological: Pembrolizumab
    PD-1 inhibitor
  • Drug: Paclitaxel
    Targets Microtubules
  • Drug: Pemetrexed
    Multitargeted Antifolate
  • Drug: Carboplatin
    Modifies DNA structure and inhibits DNA Synthesis
Study Arms  ICMJE
  • Experimental: Cohort A - Participants with non-squamous NSCLC
    Participants in this arm will receive EIK1001 + Standard of Care (SOC).
    Interventions:
    • Drug: EIK1001
    • Biological: Pembrolizumab
    • Drug: Pemetrexed
    • Drug: Carboplatin
  • Experimental: Cohort B - Participants with squamous NSCLC
    Participants in this arm will receive EIK1001 + Standard of Care (SOC).
    Interventions:
    • Drug: EIK1001
    • Biological: Pembrolizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2024)		 70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brage Garofalo, M.A. (341) 777-0566 garofalob@eikontx.com
Contact: Surya Vangala (341) 777-0566 vangalas@eikontx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06246110
Other Study ID Numbers  ICMJE EIK1001-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eikon Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eikon Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Etah Kurland, MD Eikon Therapeutics
Study Director: Wale Akinseli, MD, MPH Eikon Therapeutics
PRS Account Eikon Therapeutics
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP