Clinical trial · Observational
Immune and Genomic Markers in ALK+ NSCLC
Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
NCT04881916CI-TRIAL-00106821active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Lymphoma Kinase Gene Translocation | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Sample Collection
- description
- 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.
Primary outcomes (1)
- measure
- Registry Establishment
- timeFrame
- Up to 2 years
- description
- 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.
Secondary outcomes (5)
- measure
- Duration Of Therapy
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLiang 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