Carcinoma, Non-small Cell Lung Clinical Trial
Official title:
A Prospective Observational Study of Comprehensive Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer
NCT number | NCT02671045 |
Other study ID # | COTA 14001 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | August 2017 |
Verified date | July 2018 |
Source | Cota Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 649 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | COTA | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Cota Inc. | Foundation Medicine, Horizon Blue Cross Blue Shield of New Jersey, Regional Cancer Care Associates LLC |
United States,
Drilon A, Wang L, Arcila ME, Balasubramanian S, Greenbowe JR, Ross JS, Stephens P, Lipson D, Miller VA, Kris MG, Ladanyi M, Rizvi NA. Broad, Hybrid Capture-Based Next-Generation Sequencing Identifies Actionable Genomic Alterations in Lung Adenocarcinomas Otherwise Negative for Such Alterations by Other Genomic Testing Approaches. Clin Cancer Res. 2015 Aug 15;21(16):3631-9. doi: 10.1158/1078-0432.CCR-14-2683. Epub 2015 Jan 7. — View Citation
Gutierez M, Harper H, Halliby BE. Impact and utilization of genomic profiling in metastatic non-small cell lung cancer in the community setting. J Clin Oncol 33, 2015 (suppl; abstr e19113)
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with all cause mortality | Comparison by cohorts | Completion of study (estimated 5 years) | |
Secondary | Number of participants with a mutation of EGFR | Comparison by cohorts | 5 years | |
Secondary | Number of paticipants with a rearrangment of ALK | Comparison by cohorts | 5 years | |
Secondary | Number of participants with a genomic alteration with an available targeted therapy (as defined by NCCN guideline matching) | Comparison by cohorts | 5 years | |
Secondary | Number of participants that receive a targeted therapy for a genomic mutation (as defined by NCCN guideline matching) | Comparison by cohorts | 5 years | |
Secondary | ECOG performance scores | Comparison by cohorts | 5 years | |
Secondary | "Living with Cancer" Patient Reported Outcome Metric | Comparison by cohorts. The "LWC" Metric has been established and validated by COTA | 5 years | |
Secondary | Number of participants with all cause mortality in Non squamous cell lung cancer histologies (subgroup) | Comparison by cohorts | 5 years | |
Secondary | Total cost of care (based on insurance claims data) for all participants | Comparison by cohorts | 5 years |
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