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

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.

Sex

All

Minimum age

18 Years

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.

• BACKGROUNDDrilon 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. PMID 25567908
• BACKGROUNDGutierez 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)