Noninvasive vs. Invasive Lung Evaluation (NILE)
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|ClinicalTrials.gov Identifier: NCT03615443|
Recruitment Status : Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : November 3, 2020
Guardant Health, Inc.
Information provided by (Responsible Party):
Guardant Health, Inc.
Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Diagnostic Test: Guardant360||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Noninvasive vs. Invasive Lung Evaluation|
|Actual Study Start Date :||February 12, 2016|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
|Treatment-naive metastatic non-squamous NSCLC||
Diagnostic Test: Guardant360
Guardant360 is a comprehensive, non-invasive tumor sequencing test.
Primary Outcome Measures :
- Demonstrate the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping [ Time Frame: 34 months ]The proportion of subjects for whom a genetic alteration is found in at least one of seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) by testing tumor tissue will be compared to the proportion of subjects for whom a genetic alteration is found in at least one of the same genes by testing cfDNA.
Secondary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: 34 months ]The proportion of subjects with complete or partial tumor response as determined by the investigator. This will be assessed for the overall population and for the subpopulation of subjects who are identified by either tissue or cfDNA as having actionable EGFR activating mutations, ALK fusions, ROS1 fusions, and BRAF V600E mutations and who are subsequently treated with tyrosine kinase inhibitors.
- Turnaround Time for cfDNA vs. Tissue Results [ Time Frame: 34 months ]The time (in days) from the date of request for genetic testing to the report date for cfDNA and for tumor tissue.
- Time to Treatment Initiation [ Time Frame: 34 months ]The number of days from the date of study enrollment until the date that systemic or localized treatment is initiated.
- Quantity Not Sufficient Rate of Tissue for Complete NCCN Biomarker Testing [ Time Frame: 34 months ]The proportion of subjects deemed to have quantity not sufficient for tumor tissue testing of any of seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) due to any of the following reasons: 1) insufficient tumor specimen for the genotyping tests to be performed, or 2) tumor cellularity below lab-dictated minimal requirements, or 3) no results available within 45 days of enrollment.
- Tissue Incomplete Rate of Tissue for NCCN Biomarker Testing [ Time Frame: 34 months ]The proportion of subjects with tumor tissue testing results not available for all seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) and with no alterations detected among the genes that were tested.
- Tumor Not Detected Rate of cfDNA in Blood [ Time Frame: 34 months ]The proportion of subjects for whom cfDNA could not be detected in blood.
- Sensitivity, Specificity, and Diagnostic Accuracy of Non-NCCN Biomarkers on the Guardant360 Panel [ Time Frame: 34 months ]This objective applies to genes included in the Guardant360 panel other than EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET and to subjects for whom both cfDNA and tumor tissue testing results are available. Diagnostic accuracy will include calculations for sensitivity, specificity, positive predictive value, and negative predictive value comparing tissue to cfDNA results and vice versa.
- Rate of Discovery of Genomically Mediated, Acquired Resistance to Targeted Therapies in the Biomarker-Positive Subsets [ Time Frame: 34 months ]Among subjects with tumor genetic alterations in EGFR, ALK, ROS1, BRAF, MET, ERBB2, or RET, the proportion with new (compared to baseline) genetic alterations in cfDNA at the time of disease progression following treatment with a therapy targeting the specific genetic alteration.
Other Outcome Measures:
- Liquid Biopsy Rescue Rate of QNS Tissue Samples [ Time Frame: 34 months ]Among subjects with tumor tissue quantity not sufficient for genetic testing, the proportion that had cfDNA detected.
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