A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer
Rohan Maniar
Primary Investigator
Brief 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.
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.