Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)

NCT03248089 | Completed

• 1 other identifier: MedOPP125
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 7

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• 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

  From the date of enrollment in the study until D1 (treatment initiation)

• Quantity not sufficient rate (QNS) of tissue

  From day 0 to pre-treatment visit

• Tissue Incomplete (TI) rate of tissue

  From day 0 to pre-treatment visit

• Tumor Not Detected (TND) rate of cell free DNA (cfDNA)

  From pre-treatment visit until month 12 or upon progression, whichever occurs first

Interventions

Guardant360 DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedSIR: lead
• Guardant Health, Inc.: collaborator

Study Sites (7)

H. Can Ruti

Badalona, Spain

Location

Dexeus

Barcelona, Spain

Location

H. del Mar

Barcelona, Spain

Location

H. Sant Pau

Barcelona, Spain

Location

H. Vall Hebrón

Barcelona, Spain

Location

ICO Bellvitge

L'Hospitalet de Llobregat, Spain

Location

H. Arnau de Vilanova

Valencia, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

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).

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rafael Rosell

  IOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 14, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)