NCT04881916Active, not recruiting
Immune and Genomic Markers in ALK+ NSCLC
Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 6 May 2021
- Start date
- 1 Dec 2021
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Lung cancer
- NCT number
- NCT04881916
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Dec 2021 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have previously enrolled to the study.
Other illness
- Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
Age
- Participants who are younger than 18 years of age.
Other
- Participants who are unwilling to provide informed consent.
- Participants who are unable to comply with the study procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.