Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP) | NCT03248089

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

NCT03248089

Sponsor

MedSIR

Status

Completed

Last Update Posted

Jan 9, 2019Actual

Enrollment

186Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Guardant360

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jan 2019Actual

First Submitted Date

Aug 1, 2017

First Submission Date that Met QC Criteria

Aug 9, 2017

First Posted Date

Aug 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2019

Last Update Posted Date

Jan 9, 2019Actual

Name	Class
Guardant Health, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

186Actual

Name	Type	Description	Arm Group Labels	Other Names
Guardant360	Diagnostic Test	Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Rafael Rosell	IOR	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Approximately 20 mL of peripheral blood will be collected in StreckTM tubeS. cfDNA will be drawn following blood withdraws following standard of care of the participating site, which would be, before treatment (v2); on the same date as the first standard of care labs (V3), which would be approximately 2 weeks (14 days) into first-line treatment and after one year from enrollment or upon progression whichever occurs first (EoS visit).

enrollment or upon progression whichever occurs first (EoS visit).

Facility	Status	City	State	ZIP	Country	Contacts
H. Can Ruti		Badalona			Spain
Dexeus