Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP) (SLLIP)

Spanish Lung Liquid vs. Invasive Biopsy Program

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Guardant360

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.

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• Spain
  • Badalona, Spain
    • H. Can Ruti
  • Barcelona, Spain
    • H. del Mar
  • Barcelona, Spain
    • Dexeus
  • Barcelona, Spain
    • H. Vall Hebron
  • Barcelona, Spain
    • H. Sant Pau
  • L'Hospitalet de Llobregat, Spain
    • ICO Bellvitge
  • Valencia, Spain
    • H. Arnau de Vilanova

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

182 patients with previously untreated non-small cell lung cancer (NSCLC), non-squamous subtype will be recruited for this study, wherein Cell free DNA (cfDNA) will be compared to biopsy-based tumor sequencing

Description

Inclusion Criteria:

• Patients biopsy-proven, metastatic, previously untreated, non-squamous non-small cell lung cancer (NSCLC). Patients may have received adjuvant cytotoxic chemotherapy, but not targeted neo-adjuvant or adjuvant therapy.
• Age ≥ 18 years
• Ability to understand a written informed consent document, and the willingness to sign it.
• Willingness to provide blood sample at the time points defined in Table 1 [pre-treatment, Day 14 (+/- 7 days) and End of Study].
• Patient has or will have standard-of-care tissue genotyping ordered.
• Stable Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

• Pregnancy, recorded from clinical records
• Any concurrent, non-cutaneous, malignancy (with the exception of early stage non-invasive cervical cancer). Any prior cancer must have occurred more than 5 years prior with no evidence of currently active disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping	Demonstrate the non-inferiority of cell free DNA (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 Non-small cell lung cancer (NSCLC).	From date of inclusion until 12 months from enrollment follow-up or upon progression, death or withdrawal from study participation, whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results	Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results	From pre-treatment visit until month 12 or upon progression, whichever occurs first
Time to treatment (TtT) initiation	Time to treatment (TtT) initiation	From the date of enrollment in the study until D1 (treatment initiation)
Quantity not sufficient rate (QNS) of tissue	Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing	From day 0 to pre-treatment visit
Tissue Incomplete (TI) rate of tissue	Tissue Incomplete (TI) rate of tissue for National Cancer Center Network (NCCN) biomarker testing	From day 0 to pre-treatment visit
Tumor Not Detected (TND) rate of cell free DNA (cfDNA)	Tumor Not Detected (TND) rate of cell free DNA (cfDNA) in blood	From pre-treatment visit until month 12 or upon progression, whichever occurs first
Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping	Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping	From pre-treatment visit until month 12 or upon progression, whichever occurs first
Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs	Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs according investigator criteria.	From visit 0 until month 12 or upon progression, whichever occurs first
Rate of discovery of genomically mediated, acquired resistance to targeted therapies	Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.	From visit 0 until month 12 or upon progression, whichever occurs first

Collaborators and Investigators

• Sponsor: MedSIR
• Collaborators: GUARDANT HEALTH
• Investigators: Principal Investigator: Rafael Rosell, IOR

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MedOPP125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No