Active — Not RecruitingNot Applicable

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

France80 participantsStarted 2021-03-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patient with non operable and / or metastatic non-small cell lung cancer documented histologically. * Pathological diagnosis of NSCLC carrying an EGFR activating mutation associated with sensitivity to the tyrosine kinase inhibitors (TKI) (exons 18, 19 and 21). * Sufficient tissue sample quantity and quality for translational research * Naïve TKI-treated EGFR patient who can receive first-line treatment with Osimertinib or second-line after chemotherapy Exclusion Criteria: * Any patient with an exon 20 EGFR mutation. * Any disease or pathology that recommend not to perform blood samples collection * Any psychological, family, geographical or social condition that could potentially, according to the investigator's judgment, prevent the collection of informed consent or interfere with compliance with the study protocol * Patient with a resistance mutation of EGFR * Patient under State Medical Assistance * Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curatorship or safeguard of justice

What they're measuring

Rate of EGFR mutated patients for whom phenotypic characterization of DTC-like and osimertinib-tolerant tumor cells is feasible.

Timeframe: Up to one year or progression

Trial details

NCT IDNCT04222335

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12