Immune and Genomic Markers in ALK+ NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881916
• Other study ID #: 20-237
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Jessica J Lin, MD
• Phone: 617-724-4000
• Email: jjlin1[@]partners.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Lymphoma Kinase Gene Translocation
• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Addario Lung Cancer Medical Institute, LUNGevity Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration Of Therapy	To determine the clinical outcomes (durations of therapy) on ALK Tyrosine kinase inhibitor-TKI(s) and/or immune checkpoint inhibitor-ICI(s) of ALK+ NSCLC patients. Duration of therapy will be estimated using the Kaplan-Meier method, and 95% confidence intervals (CIs) will be calculated using the log-log transformation.	Up to 2 years
Secondary	Overall survival (OS)	To determine the overall survival (OS) of ALK+ NSCLC patients treated with sequential ALK TKIs and/or ICIs. OS for patient will be estimated using the Kaplan-Meier method, and 95% confidence intervals (CIs) will be calculated using the log-log transformation Overall survival (OS) will be calculated as the time from the first dose of the drug of interest to death due to any cause.	Up to 2 years
Secondary	ALK resistance mutations	Study the development of ALK resistance mutations in the TKI-resistant tumor specimen(s) as patients receive sequential ALK-targeted therapies	Up to 2 years
Secondary	Genomic alterations	To determine the presence of genomic alterations such as single nucleotide variants, insertions or deletions, or copy number alterations in other cancer-related genes in the post-TKI tumor specimen(s).	Up to 2 years
Secondary	Tumor immunophenotype	Correlate the tumor immunophenotype such as PD-L1 expression level or tumor mutational burden (TMB) with clinical outcomes.	Up to 2 years