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.
Informed consent signed;
Age ≥ 18 years;
Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
Received adjuvant therapy other than that specified in the ADAURA study;
No NGS test report at recurrence;
History of other malignant tumors within 2 years;
This multicenter, retrospective, real-world study includes patients with resected stage IB-IIIA NSCLC harboring EGFR-sensitizing mutations (exon 19 deletion or exon 21 L858R) who received adjuvant osimertinib. A total of 60 patients are enrolled and classified into two cohorts based on recurrence timing: Cohort 1 comprises 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib; Cohort 2 comprises 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed. All data are extracted from electronic medical records.
Cohort
Retrospective
Not listed
Recurrence gene profiles
To assess the recurrence gene profiles of adjuvant Osimertinib therapy
Recurrence gene profiles in patients with different recurrence types (local /distant)
To explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy
Subsequent treatment patterns
To describe the diverse treatment patterns (Osi or other EGFR TKIs，± chemo) in real clinical practice after the disease progressed
Investigate the mechanisms driving tumor progression
The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression
Click on the lead sponsor to view all of their trials.
