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

Purpose

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

  • NSCLC

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: Pembrolizumab
    PD-1 inhibitor
  • Drug: Pemetrexed
    Chemotherapy
  • Drug: Carboplatin
    Chemotherapy
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
  • Drug: Pembrolizumab
    PD-1 inhibitor
  • Drug: Paclitaxel
    Chemotherapy
  • Drug: Carboplatin
    Chemotherapy

Recruiting Locations

Medstar Franklin Square Cancer Center at Loch Raven Campus
Baltimore, Maryland 21237
Contact:
Amy Avergas
443-777-7000
amy.m.avergas@medstar.net

More Details

Status
Recruiting
Sponsor
Eikon Therapeutics

Study Contact

Brage Garofalo, M.A.
(341) 777-0566
garofalob@eikontx.com

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.