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

Part of paid clinical trials in Mineola, New York.

Sponsor
Eikon Therapeutics
Study ID
NCT07365319
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EIK1001 — DRUG
    EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
  • Pembrolizumab (KEYTRUDA®) — DRUG
    PD-1 inhibitor
  • Placebo — DRUG
    Placebo control
  • Paclitaxel + Carboplatin — DRUG
    SOC Chemotherapy for squamous NSCLC
  • Nab-paclitaxel + Carboplatin — DRUG
    SOC Chemotherapy for squamous NSCLC
  • Pemetrexed + Cisplatin /Carboplatin — DRUG
    SOC Chemotherapy for non-squamous NSCLC

Study Details

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.

Key Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2040

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1 (Placebo in Combination with SOC)
    Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
  • Experimental: Arm 2 (EIK1001 in Combination with SOC)
    Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
  • Experimental: Arm 3 (EIK1001 in Combination with SOC)
    Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Through study completion, up to 6 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NYU Langone Hospital Long IslandMineolaNew York11501-
NYU Langone Hospital ManhattanNew YorkNew York10016-
White Plains HospitalWhite PlainsNew York10601-

Find similar trials in Mineola, NY

By research site
NYU Langone Hospital Long Island· Mineola, NYNYU Langone Hospital Manhattan· New York, NYWhite Plains Hospital· White Plains, NY

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