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Completed NCT06477055

The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer

Conditions: Non-small Cell Lung Cancer

Sex: All
Healthy volunteers: No
Enrollment: 43
Sponsor: Hunan Province Tumor Hospital

Location: Hunan Provincal Tumor Hospital Changsha Hunan

Summary

This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.

Eligibility Criteria

Inclusion Criteria: 1. Informed consent signed; 2. Age ≥ 18 years; 3. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer; 4. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection; 5. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy; 6. Recurrence after/on Osimertinib treatment according to RECIST 1.1; 7. NGS gene test report (tumor or blood sample) at the time of recurrence; Exclusion Criteria: 1. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed; 2. Received adjuvant therapy other than that specified in the ADAURA study; 3. No NGS test report at recurrence; 4. History of other malignant tumors within 2 years; 5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06477055). StuddyBuddy aggregates publicly available trial information.