← Back to all trials
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.
Source: ClinicalTrials.gov (NCT06477055). StuddyBuddy aggregates publicly available trial information.