Clinical trial NCT03248089: Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)
Official title: Spanish Lung Liquid vs. Invasive Biopsy Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: MedSIR
Sponsor class: OTHER
Collaborators: name: Guardant Health, Inc.
First posted: 2017-08-14
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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

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.

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

Primary outcomes:
measure: Non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping
timeFrame: 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: Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results
timeFrame: From pre-treatment visit until month 12 or upon progression, whichever occurs first
measure: Time to treatment (TtT) initiation
timeFrame: From the date of enrollment in the study until D1 (treatment initiation)
measure: Quantity not sufficient rate (QNS) of tissue
timeFrame: From day 0 to pre-treatment visit
measure: Tissue Incomplete (TI) rate of tissue
timeFrame: From day 0 to pre-treatment visit
measure: Tumor Not Detected (TND) rate of cell free DNA (cfDNA)
timeFrame: From pre-treatment visit until month 12 or upon progression, whichever occurs first
measure: Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping
timeFrame: From pre-treatment visit until month 12 or upon progression, whichever occurs first
measure: Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs
timeFrame: From visit 0 until month 12 or upon progression, whichever occurs first
measure: Rate of discovery of genomically mediated, acquired resistance to targeted therapies
timeFrame: From visit 0 until month 12 or upon progression, whichever occurs first
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: H. Can Ruti
city: Barcelona
country: Spain
facility: Dexeus
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: H. Sant Pau
city: Barcelona
country: Spain
facility: H. Vall Hebrón
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO Bellvitge
city: Valencia
country: Spain
facility: H. Arnau de Vilanova
Study officials:
affiliation: IOR
name: Rafael Rosell
role: PRINCIPAL_INVESTIGATOR
References: