Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)

Lung Cancer Clinical Trial

— SLLIP  

Official title:

Spanish Lung Liquid vs. Invasive Biopsy Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248089
• Other study ID #: MedOPP125
• Status: Completed
• Start date: July 2016
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: MedSIR
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Diagnostic Test:
• Guardant360
Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.

Locations

Country	Name	City	State
Spain	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

Sponsors (2)

Lead Sponsor	Collaborator
MedSIR	GUARDANT HEALTH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to treatment (TtT) initiation	Time to treatment (TtT) initiation	From the date of enrollment in the study until D1 (treatment initiation)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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