Registry of Guardant360® Use and Outcomes In People With Advanced Cancer

Stopped early

Conditions studied: Non-small Cell Lung Cancer Metastatic

In brief

The purpose of this registry is to collect data that describes the characteristics of people with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical outcomes after receiving their results.

Key facts

Study ID

NCT03477474

Run by

Guardant Health, Inc.

People needed

311

Starts

2018-04-06

Expected to finish

2019-09-01

Last updated by the study team

2019-10-10

Who can join

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

You may qualify if…

• NSCLC, confirmed by histology or cytology
• Advanced disease, defined as: stage IIIB or IV NSCLC at the time of the qualifying Guardant360 blood collection; or for subjects with an initial diagnosis of Stage I-IIIA disease, NSCLC that is recurrent or metastatic at the time of the qualifying Guardant360 blood collection
• One of the following conditions at the time of the qualifying Guardant360 blood collection:
• No prior systemic therapy for advanced disease OR
• All three of the following conditions:
• A history of prior systemic therapy for advanced disease, 2. Disease progression within the previous four weeks, \& 3. No new systemic therapy for advanced disease
• Exclusion Criteria Subjects with a diagnosis or history of any cancer involving the lung that is not classified as NSCLC, including but not limited to small cell carcinoma, neuroendocrine or carcinoid tumor, lymphoma, mesothelioma, metastatic non-lung carcinoma, or cancer of unknown primary.

Where it is running

• Holy Cross — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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