Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients (LUNG-RESIST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04222335|
Recruitment Status : Not yet recruiting
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Nonsmall Cell||Other: Blood samples||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Other: Blood samples
Each participant will be followed-up regularly as part of the usual practice for imaging and medical consultations. During their visits, from inclusion (T0) to the end of study participation (T progression), each patient will have a blood sampling specifically for the research to analyze tumor DNA and circulating tumor cells: T0, T1month, T3 months, Tn months, T DNA C+, T progression.
This research does not include any other act or intervention specifically required for its purposes.
- Rate of EGFR mutated patients for whom phenotypic characterization of DTC-like and osimertinib-tolerant tumor cells is feasible. [ Time Frame: Up to one year or progression ]Rate of EGFR mutated patients for whom the DTC phenotype has been characterized at T0 (Baseline), T1 month, T3 month, Tn month, T antideoxyribonuclease (ADN) Circulant+, T progression
- Rate of patients for whom the molecular characterization of DTC-like cells is successfully performed. [ Time Frame: Up to one year or progression ]This rate id defined by the number of patients who are successful compared to the total number of patients. Failure is defined by a patient with circulating tumor cells for which molecular characterization of DTC-like cells could not be performed at all measurement times.
- Progression-free survival (PFS) [ Time Frame: Up to one year or progression or death ]PFS is defined as the delay between the date of the patient's inclusion and the date of progression or death. Patients alive and without progression will be censored on the date of last news or on the date of initiation of a new anti-cancer therapy (if applicable).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222335
|Contact: Julien MAZIERES, MD; PHD||+33 5 67 77 18 firstname.lastname@example.org|
|Toulouse University Hospital|
|Toulouse, Occitanie, France, 31300|
|Contact: Sandra BERNARD +33 5 61 77 85 73 email@example.com|
|Principal Investigator: Julien MAZIERES, MD; PHD|
|Sub-Investigator: Laurence BIGAY-GAME, MD; PHD|
|Sub-Investigator: Christophe HERMANT, MD; PHD|
|Sub-Investigator: Gavin PLAT, MD; PHD|
|Sub-Investigator: Audrey RABEAU, MD; PHD|
|Sub-Investigator: Nicolas GUIBERT, MD; PHD|
|Sub-Investigator: Myriam DELAUNAY, MD|
|Principal Investigator:||Julien MAZIERES, MD; PHD||Toulouse University Hospitals|