A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.

Purpose

This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.

Conditions

  • Non Small Cell Lung Cancer (Squamous or Non Squamous)
  • Stage 4 NSCLC

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participant must be ≥ 18 years old at the time of signing the informed consent. 2. Participant has a life expectancy of at least 3 months. 3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC. 4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country. 5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. 6. Participant has not received prior systemic therapy for advanced/metastatic NSCLC. Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible. 7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment. 8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is < 3yrs old).

Exclusion Criteria

  1. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC. 2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo. 3. has had major surgery (< 3 weeks prior to the first dose of study intervention administration). 4. has received a live-virus vaccination within 30 days of the start of study intervention initiation. 5. has received radiation therapy within 7 days of the first dose of study intervention administration. 6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1 (Placebo in Combination with SOC) 		Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
  • Drug: Pembrolizumab (KEYTRUDA®)
    PD-1 inhibitor
  • Drug: Placebo
    Placebo control
  • Drug: Paclitaxel + Carboplatin
    SOC Chemotherapy for squamous NSCLC
  • Drug: Nab-paclitaxel + Carboplatin
    SOC Chemotherapy for squamous NSCLC
  • Drug: Pemetrexed + Cisplatin /Carboplatin
    SOC Chemotherapy for non-squamous NSCLC
Experimental
Arm 2 (EIK1001 in Combination with SOC) 		Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
  • Drug: EIK1001
    EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
  • Drug: Pembrolizumab (KEYTRUDA®)
    PD-1 inhibitor
  • Drug: Paclitaxel + Carboplatin
    SOC Chemotherapy for squamous NSCLC
  • Drug: Nab-paclitaxel + Carboplatin
    SOC Chemotherapy for squamous NSCLC
  • Drug: Pemetrexed + Cisplatin /Carboplatin
    SOC Chemotherapy for non-squamous NSCLC
Experimental
Arm 3 (EIK1001 in Combination with SOC) 		Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
  • Drug: EIK1001
    EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
  • Drug: Pembrolizumab (KEYTRUDA®)
    PD-1 inhibitor
  • Drug: Paclitaxel + Carboplatin
    SOC Chemotherapy for squamous NSCLC
  • Drug: Nab-paclitaxel + Carboplatin
    SOC Chemotherapy for squamous NSCLC
  • Drug: Pemetrexed + Cisplatin /Carboplatin
    SOC Chemotherapy for non-squamous NSCLC

Recruiting Locations

NYU Langone Hospital Long Island
Mineola, New York 11501

NYU Langone Hospital Manhattan
New York, New York 10016

White Plains Hospital
White Plains, New York 10601

More Details

Status
Recruiting
Sponsor
Eikon Therapeutics

Study Contact

Elelta Shiferraw
314-209-3659
shiferrawe@eikontx.com

Detailed Description

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).