Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)
- Conditions
- Lung Cancer
- Registration Number
- NCT03248089
- Lead Sponsor
- MedSIR
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping From date of inclusion until 12 months from enrollment follow-up or upon progression, death or withdrawal from study participation, whichever occurs first. 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).
- Secondary Outcome Measures
Name Time Method Rate of discovery of genomically mediated, acquired resistance to targeted therapies From visit 0 until month 12 or upon progression, whichever occurs first Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.
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 Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results
Time to treatment (TtT) initiation From the date of enrollment in the study until D1 (treatment initiation) Time to treatment (TtT) initiation
Quantity not sufficient rate (QNS) of tissue From day 0 to pre-treatment visit Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing
Tissue Incomplete (TI) rate of tissue From day 0 to pre-treatment visit Tissue Incomplete (TI) rate of tissue for National Cancer Center Network (NCCN) biomarker testing
Tumor Not Detected (TND) rate of cell free DNA (cfDNA) From pre-treatment visit until month 12 or upon progression, whichever occurs first Tumor Not Detected (TND) rate of cell free DNA (cfDNA) in blood
Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs From visit 0 until month 12 or upon progression, whichever occurs first Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs according investigator criteria.
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 Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping
Trial Locations
- Locations (7)
H. Vall Hebrón
🇪🇸Barcelona, Spain
H. Arnau de Vilanova
🇪🇸Valencia, Spain
Dexeus
🇪🇸Barcelona, Spain
ICO Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
H. del Mar
🇪🇸Barcelona, Spain
H. Sant Pau
🇪🇸Barcelona, Spain
H. Can Ruti
🇪🇸Badalona, Spain