Carcinoma, Non-Small-Cell LungLIBILNCT02511288
LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Centre Leon Berard at 8 sites in France.
Trial summary
The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 900 participants
- Where
- 8 sitesFrance
- Study dates
- Jul 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced NSCLC
Who may be able to join
- Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
- Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
- Age ≥ 18 years
- Covered by a health insurance
- Signed consent
- Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
Show all 16Show fewer
- Age ≥ 18 years
- Covered by a health insurance
- Signed consent
- COHORT 3 Inclusion criteria
- Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) whatever the mutational or PD-L1 status.
- Inclusion at the time of immunotherapy treatment initiation (1st or 2nd line)
- Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
- Age ≥ 18 years
- Covered by a health insurance
- Signed consent
Who cannot join
- Patients treated before their liquid biopsy
- COHORT 2 Inclusion criteria
- Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
- Initiation of immunotherpy before their liquid biopsy
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre Saintigny, MD, PhD contact
8 sites in 1 country
France8 sites, 1 recruiting
- Active, not recruiting
Centre Hospitalier Annecy Genevois
Annecy
- Active, not recruiting
CH Fleyriat
Bourg-en-Bresse
- Active, not recruiting
Hôpital Louis Pradel
Bron, 69677
- Active, not recruiting
CHU Grenoble Alpes
Grenoble
- Recruiting
Centre Léon Bérard
Lyon, 69008
Pierre Saintigny, MD-PhD, +33 478782781, pierre.saintigny@lyon.unicancer.fr
- Active, not recruiting
CHRU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
- Active, not recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
- Active, not recruiting
Hôpital Nord Ouest
Villefranche-sur-Saône, 69655
About this study
Official title: Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer
The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies
Read the detailed description
Lung cancers are the first cause of death by cancer in the world. The majority of these patients are diagnosed at a late stage, non-eligible to a curative treatment. Due to tumoral genomic identification, it has been possible to classify NSCLC in molecular subtypes according to molecular abnormalities detection called "drivers" which can be targeted using an appropriate treatment. This change modifies the standard treatments from the very first line of treatment particularly for patients having an EGFR mutation or an ALK or ROS1 rearrangement, with a significant benefit of progression free survival. The French NCI (INCa) recommends to identify genomic alterations of a genes panel including EGFR, KRAS, BRAF, HER2, ALK and ROS1 as well as mutations in MET exon 14. However, all the patients who benefit from a targeted therapy develop resistance after a mean duration of 10-12 months after starting the treatment. In case of progression, the tumour genetic analysis through new biopsies, enables to identify these mechanisms and then to determine if the patient can benefit or not from a third generation molecule active on these mechanisms, and to have a better understanding of the disease evolution.
The detection of these alterations is routinely performed using tissular biopsies but in 10 to 20% of the cases, it is not possible.
The detection of these molecular abnormalities in the plasma, called " liquid biopsy " is a valuable non-invasive complementary approach for these patients. It is presently used in routine for detecting the EGFR mutations at diagnosis as well as for searching EGFR T790M mutation for resistant patients.
The liquid biopsies enable to detect circulating tumoral DNA.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Hematologic test, Liquid biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with advanced NSCLC and no druggable molecular alteration at time of diagnosis | |
| Cohort 2 | Patients with advanced NSCLC harboring targetable molecular alterations at time of diagnosis | |
| Cohort 3 | Patients with advanced NSCLC at time of immunotherapy introduction (1st or 2nd line) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA)
Technique: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Secondary outcomes (8)
Identification of genetic biomarkers (or molecular profiles) having a potential predictive value in the treatments response
Techniques: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Detection of the ALK and ROS1 genes translocations in the circulating DNA
Techniques: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Evaluation of the liquid biopsies role in the tumoral monitoring
Correlation between mutated allelic fractions or expression's modification with the treatment response. Techniques: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Evaluation of genomic and transcriptomic factors detectable in the plasma, associated to the immunotherapy response
Correlation between transcriptomic and genomic factors and response to immunotherapy. Techniques: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Evaluation of the spatial and temporal tumor heterogeneity under targeted therapy treatment
Techniques: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Evaluation of the miRNAs' expression in plasma as an epigenetic factor associated to treatments response
Correlation between miRNAS expression in plasma and treatment's efficacy. Techniques: miRNAs profiling using HTG technology
Measured: 5 years
Circulating tumoral cells isolation and analysis to determine the role of non-genomic and/or phenotypic factors in the treatments response.
Single cell isolation technology
Measured: 5 years
Evaluation of the resistance mechanisms to targeted therapies
Technique: ddPCR + targeted NGF, whole exome sequencing
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Saintigny, MD, PhD, Study director, pierre.saintigny@lyon.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511288
- Sponsor's protocol ID
- ET15-076 LIBIL
- Acronym
- LIBIL
- Status last verified
- Aug 2024
- First submitted
- 16 Jul 2015
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02511288
- Acronym / sponsor ID
- LIBIL / ET15-076 LIBIL
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Hematologic test, Liquid biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies
Detailed description
Lung cancers are the first cause of death by cancer in the world. The majority of these patients are diagnosed at a late stage, non-eligible to a curative treatment. Due to tumoral genomic identification, it has been possible to classify NSCLC in molecular subtypes according to molecular abnormalities detection called "drivers" which can be targeted using an appropriate treatment. This change modifies the standard treatments from the very first line of treatment particularly for patients having an EGFR mutation or an ALK or ROS1 rearrangement, with a significant benefit of progression free survival. The French NCI (INCa) recommends to identify genomic alterations of a genes panel including EGFR, KRAS, BRAF, HER2, ALK and ROS1 as well as mutations in MET exon 14. However, all the patients who benefit from a targeted therapy develop resistance after a mean duration of 10-12 months after starting the treatment. In case of progression, the tumour genetic analysis through new biopsies, enables to identify these mechanisms and then to determine if the patient can benefit or not from a third generation molecule active on these mechanisms, and to have a better understanding of the disease evolution.
The detection of these alterations is routinely performed using tissular biopsies but in 10 to 20% of the cases, it is not possible.
The detection of these molecular abnormalities in the plasma, called " liquid biopsy " is a valuable non-invasive complementary approach for these patients. It is presently used in routine for detecting the EGFR mutations at diagnosis as well as for searching EGFR T790M mutation for resistant patients.
The liquid biopsies enable to detect circulating tumoral DNA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with advanced NSCLC and no druggable molecular alteration at time of diagnosis |
| Cohort 2 | – | –Patients with advanced NSCLC harboring targetable molecular alterations at time of diagnosis |
| Cohort 3 | – | –Patients with advanced NSCLC at time of immunotherapy introduction (1st or 2nd line) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced NSCLC
Key inclusion criteria (16 listed)
- Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
- Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
- Age ≥ 18 years
- Covered by a health insurance
- Signed consent
Key exclusion criteria (4 listed)
- Patients treated before their liquid biopsy
- COHORT 2 Inclusion criteria
- Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
- Initiation of immunotherpy before their liquid biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA)
Time frame: 5 years
Technique: ddPCR + targeted NGF, whole exome sequencing
8 secondary outcomes
Identification of genetic biomarkers (or molecular profiles) having a potential predictive value in the treatments response
Time frame: 5 years
Detection of the ALK and ROS1 genes translocations in the circulating DNA
Time frame: 5 years
Evaluation of the liquid biopsies role in the tumoral monitoring
Time frame: 5 years
Evaluation of genomic and transcriptomic factors detectable in the plasma, associated to the immunotherapy response
Time frame: 5 years
Evaluation of the spatial and temporal tumor heterogeneity under targeted therapy treatment
Time frame: 5 years
Evaluation of the miRNAs' expression in plasma as an epigenetic factor associated to treatments response
Time frame: 5 years
Circulating tumoral cells isolation and analysis to determine the role of non-genomic and/or phenotypic factors in the treatments response.
Time frame: 5 years
Evaluation of the resistance mechanisms to targeted therapies
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Saintigny, MD, PhD contact
Pierre Saintigny, MD, PhD study director
pierre.saintigny@lyon.unicancer.fr
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Centre Leon Berard at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Saintigny, MD, PhD (pierre.saintigny@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.