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

NCT06477055 | Recruiting

• 1 other identifier: 2024-IIT0612
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer

Keywords

EGFR; Osimertinib

Outcome Measures

Primary Outcomes (1)

• Recurrence gene profiles

  To assess the recurrence gene profiles of adjuvant Osimertinib therapy

  From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.

Secondary Outcomes (2)

• Recurrence gene profiles in patients with different recurrence types (local /distant)

  From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records

• Subsequent treatment patterns

  From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records

Other Outcomes (1)

• Investigate the mechanisms driving tumor progression

  From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.

Study Arms (2)

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.

Interventions

Osimertinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (2)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yongchang Zhang, MD

CONTACT

13873123436; zhangyongchang@csu.edu.cn

Liang Zeng, MD

CONTACT

15974139200

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 27, 2024
• Study Start: December 2, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (2)