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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246110
• Other study ID #: EIK1001-005
• Status: Recruiting
• Phase: Phase 2
• Start date: February 6, 2024
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Eikon Therapeutics
• Contact: Brage Garofalo, M.A.
• Phone: (341) 777-0566
• Email: garofalob[@]eikontx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist

Biological:
• Pembrolizumab
PD-1 inhibitor

Drug:
• Paclitaxel
Targets Microtubules
• Pemetrexed
Multitargeted Antifolate
• Carboplatin
Modifies DNA structure and inhibits DNA Synthesis

Locations

Country	Name	City	State
United States	Medstar Franklin Square Cancer Center at Loch Raven Campus	Baltimore	Maryland
United States	Cancer and Blood Specialists of New York, White Plains Hospital	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eikon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival (OS) at Final Follow-Up	OS defined as the time from the first dose of study medication to death due to any cause	Up to 4 years
Other	Progression Free Survival (PFS)	Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression by RECIST 1.1 (Investigator) or death due to any cause, whichever occurs first	Up to 4 years
Primary	Percentage of participants with safety event during treatment	Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.	Up to 2 years
Secondary	Percentage of participants with objective response rate (ORR) and duration of response (DOR).	Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) by RECIST 1.1 and DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, as assessed by the investigator.	Up to 4 years