Research on immune and genomic markers in ALK+ non-small cell lung cancer
Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
This study is collecting health information and samples from patients with advanced ALK+ lung cancer to see if certain genetic and immune markers can help us understand their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04881916 on ClinicalTrials.gov |
What this trial studies
This research aims to create a registry of clinical data and tumor specimens from patients with advanced ALK+ non-small cell lung cancer (NSCLC). Participants will provide clinical history and, if available, tissue and saliva samples. The study will conduct comprehensive genomic and immunophenotypic analyses of these specimens to identify markers associated with clinical outcomes for ALK+ patients. This approach will facilitate both basic and translational research in understanding the disease better.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 or older with advanced ALK+ NSCLC that is not amenable to curative treatment.
Not a fit: Patients with early-stage non-small cell lung cancer or those without ALK gene rearrangements may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment options for patients with ALK+ non-small cell lung cancer.
How similar studies have performed: Other studies focusing on genomic and immunologic markers in cancer have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jessica J Lin, MD — Massachusetts General Hospital
- Study coordinator: Jessica J Lin, MD
- Email: jjlin1@partners.org
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.