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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
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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;

• Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;

• Recurrence after/on Osimertinib treatment according to RECIST 1.1;

• NGS gene test report (tumor or blood sample) at the time of recurrence;

• Receiving or not receiving neoadjuvant treatment before surgery.

Locations
Other Locations
China
Hunan Provincal Tumor Hospital
RECRUITING
Changsha
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Yongchang Zhang, MD
zhangyongchang@csu.edu.cn
13873123436
Backup
Liang Zeng, MD
15974139200
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 60
Treatments
Cohort 1
consists of 30 patients who experienced a recurrence more than 6 months after completing 3 years of adjuvant osimertinib.
Cohort 2
consists of 30 patients with recurrence during adjuvant osimertinib treatment.
Sponsors
Leads: Hunan Province Tumor Hospital

This content was sourced from clinicaltrials.gov