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

NCT ID: NCT06477055

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-06-15

Brief Summary

This is a phase II, prospective, multicenter, study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC.

Detailed Description

This is aprospective, multicenter, phase II study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC. Approximately 60 NSCLC patients with EGFR-sensitive mutations (19del, L858R) who received adjuvant osimertinib after complete resection were enrolled. The primary endpoint was to assess the recurrence gene profiles of adjuvant Osimertinib therapy. The secondary endpoint was to explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy and to describe the diverse treatment patterns in real clinical practice after the disease progressed.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

All the patients were treated with osimertinib.

Group Type: EXPERIMENTAL

Osimertinib

Intervention Type: DRUG

Osimertinib, 80mg, po, qd.

Interventions

Osimertinib

Osimertinib, 80mg, po, qd.

Intervention Type: DRUG

Eligibility Criteria

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;

8. Receiving or not receiving neoadjuvant treatment before surgery.

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongchang Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yongchang Zhang, MD

Role: CONTACT

zhangyongchang@csu.edu.cn

13873123436

Liang Zeng, MD

Role: CONTACT

15974139200

Other Identifiers

2024-IIT0612

Identifier Type: -

Identifier Source: org_study_id