Non-small Cell Lung Cancer
Conditions
Keywords
EGFR, Osimertinib
Brief 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.
Detailed description
This is a multicenter, real-world, retrospective observational study designed to investigate the genomic landscape of recurrence in patients with early-stage (clinical stage IB-IIIA) non-small cell lung cancer harboring EGFR-sensitizing mutations who received adjuvant osimertinib. A total of 60 patients with resectable EGFR-sensitizing mutation-positive NSCLC (exon 19 deletion or exon 21 L858R) are expected to be included and classified into two cohorts. Cohort 1 consists of 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib, and Cohort 2 consists of 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. The primary endpoint is to evaluate the genomic landscape of recurrence during or after adjuvant osimertinib treatment in patients with resectable NSCLC harboring EGFR-sensitizing mutations. The secondary endpoints are to explore the genomic profiles of recurrence in subgroups with different recurrence patterns (local recurrence versus distant metastasis) during or after adjuvant osimertinib treatment, and to describe the treatment patterns used in real-world clinical practice after disease progression. The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression.
Interventions
None listed
Sponsors
Hunan Province Tumor Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence gene profiles | From January 2021 to March 2026, assessed retrospectively from medical records. | To assess the recurrence gene profiles of adjuvant Osimertinib therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence gene profiles in patients with different recurrence types (local /distant) | From January 2021 to March 2026, assessed retrospectively from medical records | To explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy |
| Subsequent treatment patterns | FromJanuary 2021 to March 2026, assessed retrospectively from medical records | To describe the diverse treatment patterns (Osi or other EGFR TKIs，± chemo) in real clinical practice after the disease progressed |
Countries
China
Outcome results
None listed