NCT02511288

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2015Dec 2026

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

10.7 years

First QC Date

July 16, 2015

Last Update Submit

August 20, 2024

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Hematologic testLiquid biopsy

Outcome Measures

Primary Outcomes (1)

  • Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA)

    Technique: ddPCR + targeted NGF, whole exome sequencing

    5 years

Secondary Outcomes (8)

  • Identification of genetic biomarkers (or molecular profiles) having a potential predictive value in the treatments response

    5 years

  • Detection of the ALK and ROS1 genes translocations in the circulating DNA

    5 years

  • Evaluation of the liquid biopsies role in the tumoral monitoring

    5 years

  • Evaluation of genomic and transcriptomic factors detectable in the plasma, associated to the immunotherapy response

    5 years

  • Evaluation of the spatial and temporal tumor heterogeneity under targeted therapy treatment

    5 years

  • +3 more secondary outcomes

Study Arms (3)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced NSCLC

You may qualify if:

  • 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

You may not qualify if:

  • \- Patients treated before their liquid biopsy
  • 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.
  • 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
  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) whatever the mutational or PD-L1 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
  • \- Initiation of immunotherpy before their liquid biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Centre Hospitalier Annecy Genevois

Annecy, France

ACTIVE NOT RECRUITING

CH Fleyriat

Bourg-en-Bresse, France

ACTIVE NOT RECRUITING

Hôpital Louis Pradel

Bron, 69677, France

ACTIVE NOT RECRUITING

CHU Grenoble Alpes

Grenoble, France

ACTIVE NOT RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

CHRU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

ACTIVE NOT RECRUITING

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

ACTIVE NOT RECRUITING

Hôpital Nord Ouest

Villefranche-sur-Saône, 69655, France

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pierre Saintigny, MD, PhD

    pierre.saintigny@lyon.unicancer.fr

    STUDY DIRECTOR

Central Study Contacts

Pierre Saintigny, MD, PhD

CONTACT

pierre.saintigny@lyon.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 30, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

FR(8)