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)
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.
Study Type
OBSERVATIONAL
Enrollment
100
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
ALK resistance mutations
Study the development of ALK resistance mutations in the TKI-resistant tumor specimen(s) as patients receive sequential ALK-targeted therapies
Time frame: Up to 2 years
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).
Time frame: Up to 2 years
Tumor immunophenotype
Correlate the tumor immunophenotype such as PD-L1 expression level or tumor mutational burden (TMB) with clinical outcomes.
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Time frame: Up to 2 years