Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)

Spanish Lung Liquid vs. Invasive Biopsy Program

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.

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.

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