Lung Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTGuardant360
Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.
Sponsors
Guardant Health, Inc.
MedSIR
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
Countries
Spain
Outcome results
None listed