Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)

NCT ID: NCT03248089

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 186 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-01-31

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

Guardant360

Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guardant Health, Inc.

INDUSTRY

Sponsor Role: collaborator

MedSIR

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Rosell

Role: PRINCIPAL_INVESTIGATOR

IOR

Locations

H. Can Ruti

Badalona, , Spain

Dexeus

Barcelona, , Spain

H. del Mar

Barcelona, , Spain

H. Sant Pau

Barcelona, , Spain

H. Vall Hebrón

Barcelona, , Spain

ICO Bellvitge

L'Hospitalet de Llobregat, , Spain

H. Arnau de Vilanova

Valencia, , Spain

Countries

Spain

Other Identifiers

MedOPP125

Identifier Type: -

Identifier Source: org_study_id