RecruitingNot ApplicableNCT04222335

Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients

Sponsor

University Hospital, Toulouse

Enrollment

80 participants

Start Date

Mar 26, 2021

Study Type

INTERVENTIONAL

Conditions

Lung Cancer, Nonsmall Cell

Summary

Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) are effective therapies for advanced lung cancer patients bearing EGFR-activating mutations, but are not curative due to the invariable apparition of resistances. The investigator team have identified a new phenotype related to drug tolerance after EGFR-TKI treatment that shares several characteristics of a known process of Therapy-Induced Senescence (TIS), which could be a major event of drug tolerance in patients. Using cutting-edge technologies, patient-derived xenografts (PDX) and circulating tumor cells (CTC), the investigator team will perform an exhaustive characterization of the phenotypic and molecular changes associated with this drug-tolerant state in patients. Their results should lead to new therapeutic approaches to eliminate the reservoir of drug-tolerant cells and to prevent emergence of resistance mutations responsible for the relapse of patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at why some lung cancers with a specific gene mutation (EGFR) stop responding to targeted therapy (TKI drugs like osimertinib) over time. Researchers want to understand the mechanisms of resistance by analyzing blood and tissue samples. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC) that cannot be surgically removed or has spread - Your tumor has a specific EGFR gene mutation (in exons 18, 19, or 21) that is known to respond to targeted therapy - You are starting or have recently started treatment with a TKI drug (like osimertinib) as first-line therapy, or after chemotherapy - You have enough tumor tissue available for research testing **You may NOT be eligible if...** - Your tumor has an EGFR exon 20 mutation - Your tumor already has a known resistance mutation - You have serious health or social circumstances that would prevent participation - You are under state medical assistance or have legal guardianship restrictions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood 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.