Immune and Genomic Markers in ALK+ NSCLC

Mass General Brigham

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT04881916

20-237

Details and patient eligibility

About

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)

Full description

The purpose of this study is to establish a registry of clinical data and tumor specimens of patients with advanced ALK+ non-small lung cancer (NSCLC) (defined as NSCLC harboring an ALK gene rearrangement). This will allow in-depth, comprehensive genomic and immunophenotypic analyses of ALK+ tumors. Together with the clinical data, these biologic specimens will enable the conduct of basic and translational research to identify genomic and immunologic markers associated with clinical outcomes for ALK+ patients.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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.

Trial design

100 participants in 1 patient group

Sample Collection

Description:

Participation In: * Initial data completion: Telephone collection of information on disease, treatment and testing * Medical record collection: Collection of medical records regarding cancer, testing, and treatment history * Archival tissue collection: Collection of tumor from prior standard of care procedure * Saliva collection: Saliva collection with at home kit * Follow up data completion: Telephone collection of medical condition every 3-6 months up to 2 years.