Immune and Genomic Markers in ALK+ NSCLC

Running, not enrolling

Conditions studied: Anaplastic Lymphoma Kinase Gene Translocation, Non-Small Cell Lung Cancer

In brief

The purpose of this research study is to obtain and study clinical history, and tissue and saliva specimens if available from participants with Anaplastic Lymphoma Kinase-ALK+ Non-Small Lung Cancer(NSCLC)

Key facts

Study ID

NCT04881916

Run by

Massachusetts General Hospital

People needed

100

Starts

2021-12-01

Expected to finish

2027-07-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort 1 - Alive Individuals
• Men or women 18 years of age or the age of majority for their residential state of the United States, or older, at the time of consent.
• Histologically or cytologically confirmed advanced stage IIIB-IIIC not amenable to curative approach multi-modality (e.g., chemoradiation and/or surgery) treatment, or stage IV non-small cell lung cancer (NSCLC)
• Demonstration of having advanced ALK+ NSCLC, as assessed by fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), next-generation sequencing (NGS) or circulating tumor DNA analysis (ctDNA). For ALK FISH, fusions must have been detected in at least 15% of tumor cells.
• Willingness to provide clinical and medical information to the study team as required.
• Willingness to provide archival tumor tissue, if available. Patients may enroll even if no tumor tissue is available.
• Ability to read, write and communicate in English.
• Ability to sign a web-based informed consent form.
• Cohort 2 - Deceased Individuals
• Deceased individuals diagnosed with advanced ALK+ lung cancer at age 18 years or older may be studied on a case by case basis. Inclusion will require availability of adequate archived tissue and release of tissue and records by next of kin, if available.

You may not qualify if…

• Participants who are unwilling to provide informed consent.
• Participants who are younger than 18 years of age.
• Participants who are unable to comply with the study procedures.
• Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
• Participants who have previously enrolled to the study.

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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