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Active Surveillance for Non-Small Cell Lung Cancer

N/A

Recruiting

Led By Meghan Mooradian, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to see if using a blood test for circulating tumor DNA can help doctors decide when to stop therapy in patients with melanoma or lung cancer. They want to know if patients with these cancers

Who is the study for?

This trial is for adults over 18 with metastatic melanoma or NSCLC who've been on immunotherapy for at least a year and show disease control. They must have had no serious side effects from the therapy, have tumor tissue available for testing, and be expected to live more than 3 months.Check my eligibility

What is being tested?

The study evaluates if measuring ctDNA after one year of immunotherapy can help decide when to stop treatment in patients with melanoma or non-small-cell lung cancer, comparing their disease-free survival against past data.See study design

What are the potential side effects?

Since this trial involves monitoring ctDNA levels rather than testing new drugs, there are no direct side effects from the intervention being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluate the 12month disease-free survival (DFS) in ctDNA negative patients

Secondary outcome measures

Overall survival of the ctDNA negative cohort

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active SurveillanceExperimental Treatment1 Intervention

Patients with 12 month history of immune checkpoint inhibitors (ICI) with stable or partial or complete responses and negative ctDNA at pre-screening, will stop ICI therapy and begin active surveillance with blood draws and standard of care imaging for 12 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,934 Previous Clinical Trials

13,198,542 Total Patients Enrolled

Foundation MedicineIndustry Sponsor

32 Previous Clinical Trials

16,153 Total Patients Enrolled

Meghan Mooradian, MDPrincipal InvestigatorMassachusetts General Brigham

Frequently Asked Questions

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

How many participants are enrolled in this clinical study in its entirety?

"Indeed, data available on clinicaltrials.gov indicates that this particular medical research is actively enrolling participants. The trial was first listed on January 10th, 2024 and last modified on March 14th, 2024. It aims to enroll a total of 39 patients from one designated site."

Answered by AI

Are new patients currently being accepted for enrollment in this medical study?

"Indeed, the details on clinicaltrials.gov demonstrate that this research endeavor is presently seeking eligible individuals. Initially shared on January 10th, 2024, and subsequently revised on March 14th, 2024, the investigation aims to enroll a total of 39 participants at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation

Meghan Mooradian 2024. "Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06146920.