NCT06477055

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

A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Timeline

• Start date: 2025-12-02
• Primary completion: 2026-03-31
• Completion: 2026-04-30
• First posted: 2024-06-27
• Last updated: 2026-04-13

Locations

2 sites across 1 country: China