← Back to Search
Cancer Vaccine
EIK1001 + Pembrolizumab and Chemotherapy for Non-Small Cell Lung Cancer
Daphne, AL
Phase 2
Recruiting
Research Sponsored by Eikon Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be ≥ 18 years of age on the day of signing of informed consent
Have not received prior systemic treatment for advanced/metastatic NSCLC
Must not have
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
Has an active infection requiring therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is for patients with advanced lung cancer who have not yet received intravenous treatment.
See full description
Who is the study for?
This trial is for adults with advanced stage 4 non-small cell lung cancer who haven't had intravenous treatment for their condition. Specific eligibility details are not provided, but typically participants need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments.Check my eligibility
What is being tested?
The study tests a combination of EIK1001 with the immunotherapy drug Pembrolizumab and chemotherapy drugs Paclitaxel, Pemetrexed, and Carboplatin. It's likely that patients will be randomly assigned to receive either this combination or a standard treatment as part of the research.See study design
What are the potential side effects?
Potential side effects from these treatments can include immune-related reactions due to Pembrolizumab, nerve damage or hair loss from Paclitaxel, fatigue from Pemetrexed, and blood count changes from Carboplatin. EIK1001's specific side effects aren't detailed but would be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
show original
Select...
I haven't had systemic treatment for advanced lung cancer.
show original
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
show original
Select...
My lung cancer is at stage 4 and I am eligible for standard treatments.
show original
Select...
My cancer does not have mutations that can be treated with targeted therapy.
show original
Select...
I have at least one tumor that can be measured.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung cancer is not mainly squamous or non-squamous cell type.
show original
Select...
I am currently being treated for an infection.
show original
Select...
I finished palliative radiotherapy less than a week ago.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants with safety event during treatment
Secondary study objectives
Percentage of participants with objective response rate (ORR) and duration of response (DOR).
Other study objectives
Overall Survival (OS) at Final Follow-Up
Progression Free Survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B - Participants with squamous NSCLCExperimental Treatment4 Interventions
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
Group II: Cohort A - Participants with non-squamous NSCLCExperimental Treatment4 Interventions
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2630
Pemetrexed
2014
Completed Phase 3
~4980
Paclitaxel
2011
Completed Phase 4
~5450
Carboplatin
2014
Completed Phase 3
~6450
Find a Location
Closest Location:Southern Cancer Care· Daphne, AL
Who is running the clinical trial?
Eikon TherapeuticsLead Sponsor
7 Previous Clinical Trials
1,149 Total Patients Enrolled
Etah Kurland, MDStudy DirectorEikon Therapeutics
Wale Akinseli, MD, MPHStudy DirectorEikon Therapeutics