Clinical trial NCT06246110: A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
Official title: A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC
Keywords: Squamous
Nonsquamous
Metastatic
Lead sponsor: Eikon Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. 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.
3. 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).
4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
5. 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.
6. has an active infection requiring therapy.

Primary outcomes:
measure: Percentage of participants with safety event during treatment
timeFrame: Up to 2 years
Secondary outcomes:
measure: Percentage of participants with objective response rate (ORR) and duration of response (DOR).
timeFrame: Up to 4 years
Other outcomes:
measure: Overall Survival (OS) at Final Follow-Up
timeFrame: Up to 4 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 4 years
Locations:
city: Daphne
country: United States
facility: Southern Cancer Care
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Fresno
country: United States
facility: California Cancer Care Associates for Research & Excellence
state: California
city: Los Angeles
country: United States
facility: California Research Institute
state: California
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
state: California
city: Sacramento
country: United States
facility: Sutter Health Institute for Medical Research
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer
state: Colorado
city: Hialeah
country: United States
facility: Bioresearch Partner
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Orange
country: United States
facility: Mid-Florida Hematology and Oncology Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Piedmont Hospital
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Tinley Park
country: United States
facility: Accelacare of Duly
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Overland Park
country: United States
facility: Health Midwest Oncology Associates of Kansas
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Medstar Franklin Square Cancer Center at Loch Raven Campus
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology
state: Maryland
city: Neptune
country: United States
facility: Jersey Shore University Medical Center/Meridian Hematology & Oncology
state: New Jersey
city: Babylon
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine, Jacobi Medical Center
state: New York
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: Weil Cornell Medical Center
state: New York
city: White Plains
country: United States
facility: Cancer and Blood Specialists of New York, White Plains Hospital
state: New York
city: Asheville
country: United States
facility: Messino Cancer Centers
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley
state: Oregon
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, Austin
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, Bedford
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Blacksburg
country: United States
facility: Blue Ridge Cancer Care Oncology Associates SW VA
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology
state: Virginia
Study officials:
affiliation: Eikon Therapeutics
name: Etah Kurland, MD
role: STUDY_DIRECTOR
affiliation: Eikon Therapeutics
name: Wale Akinseli, MD, MPH
role: STUDY_DIRECTOR
References: