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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671045
Recruitment Status : Terminated (Insufficient accrual to Horizon Bluecross Blueshield cohort)
First Posted : February 2, 2016
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Regional Cancer Care Associates LLC
Foundation Medicine
Horizon Blue Cross Blue Shield of New Jersey
Information provided by (Responsible Party):
Cota Inc.

Brief 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.


Condition or disease Intervention/treatment
Carcinoma, Non-small Cell Lung Genetic: Genomic profile by FoundationOne Genetic: Genomic profile by other methods

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 649 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Comprehensive Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer
Study Start Date : April 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A - Genomic profile by FoundationOne
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and an actionable target has been identified and the patient/physician agree to receive the targeted therapy
Genetic: Genomic profile by FoundationOne
Proprietary comprehensive genomic profile.
Other Name: FoundationOne

B - Genomic profiling by FoundationOne
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and an actionable target has been identified. However, the patient does not receive the targeted therapy.
Genetic: Genomic profile by FoundationOne
Proprietary comprehensive genomic profile.
Other Name: FoundationOne

C - Genomic profiling by FoundationOne
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and no actionable target has been identified.
Genetic: Genomic profile by FoundationOne
Proprietary comprehensive genomic profile.
Other Name: FoundationOne

D - Genomic profile by other methods
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target has been identified and the patient/physician agrees to receive the targeted therapy.
Genetic: Genomic profile by other methods
Genomic profiling by other testing methods.
Other Name: Other methodology

E - Genomic profile by other methods
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target has been identified. However, the patient does not receive targeted therapy.
Genetic: Genomic profile by other methods
Genomic profiling by other testing methods.
Other Name: Other methodology

F - Genomic profile by other methods
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target NOT has been identified.
Genetic: Genomic profile by other methods
Genomic profiling by other testing methods.
Other Name: Other methodology

G - No genomic profiling
The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has not been sent for genomic profiling.



Primary Outcome Measures :
  1. Number of participants with all cause mortality [ Time Frame: Completion of study (estimated 5 years) ]
    Comparison by cohorts


Secondary Outcome Measures :
  1. Number of participants with a mutation of EGFR [ Time Frame: 5 years ]
    Comparison by cohorts

  2. Number of paticipants with a rearrangment of ALK [ Time Frame: 5 years ]
    Comparison by cohorts

  3. Number of participants with a genomic alteration with an available targeted therapy (as defined by NCCN guideline matching) [ Time Frame: 5 years ]
    Comparison by cohorts

  4. Number of participants that receive a targeted therapy for a genomic mutation (as defined by NCCN guideline matching) [ Time Frame: 5 years ]
    Comparison by cohorts

  5. ECOG performance scores [ Time Frame: 5 years ]
    Comparison by cohorts

  6. "Living with Cancer" Patient Reported Outcome Metric [ Time Frame: 5 years ]
    Comparison by cohorts. The "LWC" Metric has been established and validated by COTA

  7. Number of participants with all cause mortality in Non squamous cell lung cancer histologies (subgroup) [ Time Frame: 5 years ]
    Comparison by cohorts

  8. Total cost of care (based on insurance claims data) for all participants [ Time Frame: 5 years ]
    Comparison by cohorts



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All (consecutive) adult patients with untreated metastatic non-small cell lung cancer treated at a COTA center will be considered enrolled on the trial starting with enrollment of the index subject and continuing until study enrollment is completed.
Criteria

Inclusion Criteria:

  • Pathologic confirmation of non-small lung cancer (all histologies)
  • Age ≥ 18 years at the time of treatment at a COTA center
  • Documentation of metastatic (stage IV) disease
  • Untreated metastatic disease prior to the genomic testing. No treatment for metastatic lung cancer is permitted prior to genomic profiling. Prior therapy for stage 0-III lung cancer is permitted.
  • Second malignancy eligible if prior malignancy has been stable off therapy for ≥ 6 months.

Exclusion Criteria:

  • Small cell lung cancer histology
  • Non-metastatic or completely resected lung cancer
  • Treatment for metastatic disease prior to genomic testing.
  • Active second malignancy requiring therapy less than 6 months prior to lung cancer diagnosis
  • Patients may refuse to be tracked in the COTA database and/or participate in this observational study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671045


Locations
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United States, New York
COTA
New York, New York, United States, 10004
Sponsors and Collaborators
Cota Inc.
Regional Cancer Care Associates LLC
Foundation Medicine
Horizon Blue Cross Blue Shield of New Jersey
Investigators
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Principal Investigator: Martin Gutierez, MD John Theurer Cancer Center at Hackensack University Medical Center
Publications:
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Responsible Party: Cota Inc.
ClinicalTrials.gov Identifier: NCT02671045    
Other Study ID Numbers: COTA 14001
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cota Inc.:
lung cancer
genomic profile
targeted therapy
FoundationOne
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms