Clinical trial NCT04881916: Immune and Genomic Markers in ALK+ NSCLC
Official title: Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anaplastic Lymphoma Kinase Gene Translocation
Non-Small Cell Lung Cancer
Keywords: Anaplastic Lymphoma Kinase Gene Translocation
Non-Small Cell Lung Cancer
ALK
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: LUNGevity Foundation
name: Addario Lung Cancer Medical Institute
First posted: 2021-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC)

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Registry Establishment
timeFrame: Up to 2 years
Secondary outcomes:
measure: Duration Of Therapy
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: ALK resistance mutations
timeFrame: Up to 2 years
measure: Genomic alterations
timeFrame: Up to 2 years
measure: Tumor immunophenotype
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jessica J Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: