23 Participants Needed

Immune Signature Analysis for Non-Small Cell Lung Cancer

Recruiting at 2 trial locations
AP
MD
Overseen ByMargarita Dzhanumova
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Immune checkpoint inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the relationship between certain blood markers, such as circulating tumor DNA (ctDNA), and the progression of lung cancer after immunotherapy. It targets individuals with metastatic non-small cell lung cancer (mNSCLC) who have received immune checkpoint inhibitor treatments for nearly two years. Participants should have completed most of their treatment and still be eligible for maintenance chemotherapy. This research could help predict cancer progression and improve future treatments. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer care.

Will I have to stop taking my current medications?

The trial allows patients to continue maintenance chemotherapy, so you may not need to stop all your current medications. However, the protocol does not specify about other medications, so it's best to discuss with the trial team.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on using biomarkers and circulating tumor DNA (ctDNA) to better understand disease progression in lung cancer patients after immunotherapy. Unlike traditional treatments that primarily aim to shrink tumors, this approach seeks to identify specific genetic signatures that could predict how a patient's cancer might change or resist treatment. By analyzing blood and tissue samples, researchers hope to personalize future treatments and improve outcomes for patients with metastatic non-small cell lung carcinoma. This could lead to more precise and effective therapies, tailored to the unique genetic makeup of each patient's cancer.

Who Is on the Research Team?

KM

Kathryn Mileham, MD

Principal Investigator

Atrium Health Levine Cancer

Are You a Good Fit for This Trial?

Inclusion Criteria

Informed consent and HIPAA authorization for release of personal health information signed by the subject. Note: Data from tumor samples, blood samples and radiographic scans prior to enrollment date may be used.
Patients with metastatic non-small cell lung carcinoma who have completed first line pembrolizumab monotherapy or pembrolizumab-platinum doublet combination therapy who have completed at least 85% of planned doses of pembrolizumab (see Section 5 for calculation).
Must have completed pembrolizumab no more than 30 days prior to enrollment/collection of baseline sample.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immune checkpoint inhibitor treatment for at least 20 of an anticipated 24 months

20-24 months

Follow-up

Participants are monitored for disease progression and biomarker analysis after treatment completion

6 months
Blood collection and CT scans every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Biomarkers and ctDNA
  • Blood and tissue samples

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Atrium Health Wake Forest Baptist

Collaborator

Trials
3
Recruited
250+

Atrium Health Levine Cancer Institute

Collaborator

Trials
30
Recruited
4,700+

Atrium Health Wake Forest Baptist

Collaborator