Immune and Genomic Markers in ALK+ NSCLC

NCT04881916 | Active Not Recruiting

• 1 other identifier: 20-237
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Registry Establishment

  Establish a registry of clinical data and tumor specimens from goal of 100 patients with advanced ALK+ NSCLC (defined as NSCLC harboring an ALK gene rearrangement), for characterization of the immunophenotype and genomic landscape of ALK+ NSCLC.

  Up to 2 years

Secondary Outcomes (5)

• Duration Of Therapy

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• ALK resistance mutations

  Up to 2 years

• Genomic alterations

  Up to 2 years

• Tumor immunophenotype

  Up to 2 years

Study Arms (1)

Sample Collection

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC)

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

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• LUNGevity Foundation: collaborator
• Addario Lung Cancer Medical Institute: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Liang J, Waliany S, Do A, Peterson JL, Roberts P, Kennedy EA, Venanzi ES, Gainor JF, Lin JJ. ENIGMA+: a national, decentralized, remote consent study for clinical data and biospecimen collection in patients with ALK-positive advanced NSCLC. Oncologist. 2025 Sep 1;30(9):oyaf217. doi: 10.1093/oncolo/oyaf217.

  PMID: 40674592 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and saliva specimens

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jessica J Lin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)