Clinical trial · Observational
Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP)
Spanish Lung Liquid vs. Invasive Biopsy Program
NCT03248089CI-TRIAL-00036420SLLIPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guardant360 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- description
- 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 outcomes (8)
- 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
- description
- Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results
- measure
- Time to treatment (TtT) initiation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.