Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

Longitudinal Monitoring of Tumor Specific Mutations in Patients With Lung Cancer

This pilot research trial studies the collection of blood samples in monitoring tumor specific mutations in patients with non-small cell lung cancer that has spread to other places in the body or cannot be removed by surgery. Collecting blood samples may help measure the changes in lung cancer, better learn methods to track cancer in the bloodstream, and improve cancer treatments.

Study Overview

• Status: Terminated
• Conditions: Stage IV Non-Small Cell Lung Cancer AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7; Stage III Non-Small Cell Lung Cancer AJCC v7; Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.

II. Compare the sensitivity of digital droplet polymerase chain reaction (ddPCR) to that of NGS for detecting the appearance of EGFR T790M mutations in patients treated with an EGFR tyrosine kinase inhibitor.

OUTLINE:

Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are seen at all the USC facilities who have metastatic or unresectable non-small cell lung carcinoma and will be starting a new line of systemic treatment will be recruited.

Description

Inclusion Criteria:

• A diagnosis of non-small cell lung carcinoma for which the molecular profile of the primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed tissue that remains available
• Zubrod performance status 0 or 1
• Patients must have metastatic or unresectable disease and be starting a new line of systemic treatment at the time of enrollment; there are no constraints regarding the time interval between the initial collection of samples for molecular profiling studies at the time of diagnosis prior to treatment and subsequent collections of circulating cell-free deoxyribonucleic acid (DNA) or circulating tumor cells
• Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
• Ability to understand and the willingness to sign a written informed consent; Note: There will be no discrimination between type of treatment or whether they are on continuous versus intermittent therapy

Exclusion Criteria:

• Known severe anemia (hemoglobin [Hb] < 8g/dL)
• Patients will be excluded if trackable driver mutations are not identified in the primary tumor tissue

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (biospecimen collection); Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Biospecimen Collection; Undergo collection of blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood sample collection for tumor specific mutations study from patients with non-small cell lung cancer	Blood samples collected will be used to evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.	Baseline to 3 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pamela Ward, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): November 21, 2023
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2L-17-1 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2017-02277 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No