RECRUITING

A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC)

Conditions

Non-small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Nsclc NSCLC Stage IV Minimal Residual Disease Non Small Cell Lung Cancer Metastatic MRD 21-465 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see whether receiving local ablative therapy (LAT) when minimal residual disease/MRD levels are rising can reduce MRD levels and control metastatic non-small cell lung cancer/NSCLC longer compared to systemic therapy.

Official Title

A Phase II Adaptive Study of Local Ablative Therapy (LAT) for Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Using Minimal Residual Disease (MRD) as an Integral Biomarker

Quick Facts

Study Start:2022-06-15

Study Completion:2025-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05429320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* At the time of therapeutic phase enrollment, complete response radiographically (no lesions to target) * Patients with CNS-only disease (due to limited capacity of peripheral blood ctDNA to detect CNS lesions) * Planned treatment by targeted agents (e.g. tyrosine kinase inhibitors) or patient not a candidate for systemic therapy * Serious medical co-morbidities precluding radiotherapy or ablation, determined at the discretion of the treating investigator. * At the time of therapeutic phase enrollment, pregnant or lactating women. * Physical limitation to undergo stereotactic radiotherapy. * Other active malignancy within the last year except for basal cell carcinoma of the skin and in situ malignancy even if without evidence of disease.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* At the time of therapeutic phase enrollment, complete response radiographically (no lesions to target)
* Patients with CNS-only disease (due to limited capacity of peripheral blood ctDNA to detect CNS lesions)
* Planned treatment by targeted agents (e.g. tyrosine kinase inhibitors) or patient not a candidate for systemic therapy
* Serious medical co-morbidities precluding radiotherapy or ablation, determined at the discretion of the treating investigator.
* At the time of therapeutic phase enrollment, pregnant or lactating women.
* Physical limitation to undergo stereotactic radiotherapy.
* Other active malignancy within the last year except for basal cell carcinoma of the skin and in situ malignancy even if without evidence of disease.

Contacts and Locations

Study Contact

Daniel Gomez, MD

CONTACT

212-639-2087

gomezd@mskcc.org

Bob Li, MD

CONTACT

646-608-3791

lib1@mskcc.org

Principal Investigator

Daniel Gomez, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Hartford Healthcare ALLIANCE (Data collection only)

Hartford, Connecticut, 06102

United States

BAPTIST ALLIANCE - MCI (Data collection only)

Miami, Florida, 33143

United States

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Daniel Gomez, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-15

Study Completion Date2025-06-15

Study Record Updates

Study Start Date2022-06-15

Study Completion Date2025-06-15

Terms related to this study

Keywords Provided by Researchers

Non-small Cell Lung Cancer
Non Small Cell Lung Cancer Metastatic
Metastatic Non Small Cell Lung Cancer
NSCLC
NSCLC Stage IV
Minimal Residual Disease
MRD
21-465
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer
Nsclc
NSCLC Stage IV
Minimal Residual Disease
Non Small Cell Lung Cancer Metastatic