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Cancer Vaccine

Cohort B - Participants with squamous NSCLC for Non-Small Cell Lung Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is for patients with advanced lung cancer who have not yet received intravenous treatment.

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 below

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I am 18 years old or older.

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I haven't had systemic treatment for advanced lung cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer is at stage 4 and I am eligible for standard treatments.

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My cancer does not have mutations that can be treated with targeted therapy.

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I have at least one tumor that can be measured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with safety event during treatment

Secondary outcome measures

Percentage of participants with objective response rate (ORR) and duration of response (DOR).

Other outcome measures

Overall Survival (OS) at Final Follow-Up

Progression Free Survival (PFS)

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

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

Pembrolizumab

2017

Completed Phase 2

~2010

Paclitaxel

2011

Completed Phase 4

~5380

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eikon TherapeuticsLead Sponsor

5 Previous Clinical Trials

162 Total Patients Enrolled

Etah Kurland, MDStudy DirectorEikon Therapeutics

Wale Akinseli, MD, MPHStudy DirectorEikon Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates still eligible to participate in this ongoing clinical trial?

"Per clinicaltrials.gov, this study is presently not accepting new participants. The trial's initial posting was on March 1st, 2024, with the most recent update made on January 30th of the same year. While recruitment for this specific trial is inactive now, it's worth noting that there are currently 1478 other trials seeking enrollees."

Answered by AI

Has the FDA given their approval for Cohort A, which includes participants with non-squamous NSCLC?

"In this Phase 2 trial, the safety assessment for Cohort A - Individuals diagnosed with non-squamous NSCLC is graded at level 2 by our team owing to available safety data without any evidence supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06246110.