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Active Not RecruitingNot applicableNCT04881916
Official study title

Immune and Genomic Markers in ALK+ NSCLC

Study 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)

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 30, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Massachusetts General Hospital

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Massachusetts General Hospital
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
ALK→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 30, 2026. Always confirm current availability with the study team.

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