Completed

SLLIPSpanish Lung Liquid vs. Invasive Biopsy Program

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What is being collected

Data Collection

DNA Samples
Who is being recruted

Lung Diseases+4

+ Lung Neoplasms

+ Neoplasms

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: July 2016
See protocol details

Summary

Principal SponsorMedSIR
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleSpanish Lung Liquid vs. Invasive Biopsy Program
NCT03248089
Principal SponsorMedSIR
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

186 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

6 inclusion criteria required to participate
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].
Show More Criteria
2 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

H. Can Ruti

Badalona, SpainOpen H. Can Ruti in Google Maps
Suspended

Dexeus

Barcelona, Spain
Suspended

H. del Mar

Barcelona, Spain
Suspended

H. Sant Pau

Barcelona, Spain
Completed7 Study Centers