NCT03248089

Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)

Spanish Lung Liquid vs. Invasive Biopsy Program

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 186 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 primary objective of this study is to demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping.

Detailed description

Primary objective: To demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve, metastatic non-squamous NSCLC. The following secondary objectives will be studied: * Turn around Time (TAT) of cfDNA vs. tissue results. * Time to treatment (TtT) initiation. * Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing. * Tumor Not Detected (TND) rate of cfDNA in blood. * Rescue rate of QNS samples using cfDNA-derived genotyping. * Rate response for patients that are actionable biomarker positive (either in cDNA or tissue) treated with target-drugs according investigator criteria. Up to three RECIST assessments per patient will be retrospectively done by external personnel (no investigational team). * Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Guardant360	Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2019-01-01
• First posted: 2017-08-14
• Last updated: 2019-01-09

Locations

7 sites across 1 country: Spain