A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer

R
Rohan Maniar

Primary Investigator

Recruiting
18 years - 100 years
All
Phase 2
1 Location

Brief description of study

What is the purpose of this study?
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.
 
This study is for patients with advanced/metastatic non-small cells lung(NSCLC) who have not received any treatment through the vein forhe advanced disease.
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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 details include:
• The study duration will be up to 30 months.
• The treatment duration will be up to 35 cycles.
• The visit frequency will be once weekly (QW) during treatment cycles.

This study will consist of a safety run-in period in participants for each cohort before beginning
the expansion phase:
• Cohort A: nonsquamous NSCLC treated with EIK1001 + pembrolizumab + carboplatin +
pemetrexed
• Cohort B: squamous NSCLC treated with EIK1001 + pembrolizumab + carboplatin +
paclitaxel.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-small cells lung cancer, NSCLC
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:

  •   be ≥ 18 years of age on the day of signing of informed consent.
  •  confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
  •  have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
  •  have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
  •  have not received prior systemic treatment for advanced/metastatic NSCLC.
  •  have an ECOG Performance Status of 0 to 1.
  •  have adequate organ function.


Exclusion Criteria:

  •  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.
  •  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.
  •  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).
  •  has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
  •  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.
  •  has an active infection requiring therapy.

Updated on 19 Nov 2025. Study ID: CTO-EIK1001-005, 22977

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