TerminatedNot applicableNCT02671045
Official study title

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

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedGenomic profile by FoundationOne and Genomic profile by other methods

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 20, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Cota Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Cota Inc.
Interventions being studied
Genetic: Genomic profile by FoundationOne; Genetic: Genomic profile by other methods
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • COTANew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2018. Always confirm current availability with the study team.

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