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

NCT07365319 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-05-20

No results posted yet for this study

Summary

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

Interventions

DRUG

EIK1001

EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist

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

Sponsors & Collaborators

Principal Investigators

  • Nishitha Reddy · Eikon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2035-12-31
Completion
2040-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07365319 on ClinicalTrials.gov