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Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer

NCT02671045 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 649

Last updated 2018-07-20

No results posted yet for this study

Summary

Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver mutations, which when targeted with specific therapies, experience improved outcomes.

Unfortunately, identification of these mutations, although recommended in national guidelines, has been limited for a variety of factors including small biopsy samples. The broad application of a sensitive genomic profiling test, which simultaneously examines for multiple genomic alterations on limited biopsy material, could increase the identification of patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne test meets these requirements. A recent study using the FoundationOne assay identified a significant number of actionable mutations among NSCLC patients who were previously thought to be negative for mutations when tested using other approaches.

This is a non-randomized observational comparative study with various cohorts based on physician diagnostic patterns of care and biologic genomic profile status. Survival and cost information will be compared based on different use of genomic profiling.

Conditions

  • Carcinoma, Non-small Cell Lung

Interventions

GENETIC

Genomic profile by FoundationOne

Proprietary comprehensive genomic profile.

GENETIC

Genomic profile by other methods

Genomic profiling by other testing methods.

Sponsors & Collaborators

  • Regional Cancer Care Associates LLC

    collaborator UNKNOWN

  • Foundation Medicine

    collaborator INDUSTRY

  • Horizon Blue Cross Blue Shield of New Jersey

    collaborator OTHER

  • Cota Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Gutierez, MD · John Theurer Cancer Center at Hackensack University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02671045 on ClinicalTrials.gov