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

Stopped early

Conditions studied: Carcinoma, Non-small Cell Lung

In brief

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.

Key facts

Study ID

NCT02671045

Run by

Cota Inc.

People needed

649

Starts

2015-04-01

Expected to finish

2017-08-01

Last updated by the study team

2018-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• COTA — New York, New York, United States

Full record on ClinicalTrials.gov

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