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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: EIK1001 Biological: Pembrolizumab Drug: Paclitaxel Drug: Pemetrexed Drug: Carboplatin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
Actual Study Start Date : February 6, 2024
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A - Participants with non-squamous NSCLC
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
 Drug: EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist

Biological: Pembrolizumab
PD-1 inhibitor

Drug: Pemetrexed
Multitargeted Antifolate

Drug: Carboplatin
Modifies DNA structure and inhibits DNA Synthesis
Experimental: Cohort B - Participants with squamous NSCLC
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
 Drug: EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist

Biological: Pembrolizumab
PD-1 inhibitor

Drug: Paclitaxel
Targets Microtubules

Drug: Carboplatin
Modifies DNA structure and inhibits DNA Synthesis


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06246110


Contacts
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Contact: Brage Garofalo, M.A. (341) 777-0566 garofalob@eikontx.com
Contact: Surya Vangala (341) 777-0566 vangalas@eikontx.com

Locations
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United States, Maryland
Medstar Franklin Square Cancer Center at Loch Raven Campus Not yet recruiting
Baltimore, Maryland, United States, 21237
Contact: Amy Avergas    443-777-7000    amy.m.avergas@medstar.net   
United States, New York
Cancer and Blood Specialists of New York, White Plains Hospital Recruiting
White Plains, New York, United States, 10601
Contact: Katarzyna Zarychta    914-681-0600    kzarychta@wphospital.org   
Sponsors and Collaborators
Eikon Therapeutics
Investigators
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Study Director: Etah Kurland, MD Eikon Therapeutics
Study Director: Wale Akinseli, MD, MPH Eikon Therapeutics
More Information
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Responsible Party: Eikon Therapeutics
ClinicalTrials.gov Identifier: NCT06246110    
Other Study ID Numbers: EIK1001-005
First Posted: February 7, 2024    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eikon Therapeutics:
Squamous
Nonsquamous
Metastatic
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Carboplatin
Pembrolizumab
 Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors