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

Phase 2

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Osimertinib

• Registration Number: NCT06477055
• Lead Sponsor: Hunan Province Tumor Hospital

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Study Start: 2024-08-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Osimertinib	All the patients were treated with osimertinib.

Primary Outcome Measures

Name	Time	Method
Recurrence gene profiles	Time from first subject dose to study completion, or up to 36 month	To assess the recurrence gene profiles of adjuvant Osimertinib therapy

Secondary Outcome Measures

Name	Time	Method
Subsequent treatment patterns	Time from first subject dose to study completion, or up to 36 month	To describe the diverse treatment patterns (Osi or other EGFR TKIs，± chemo) in real clinical practice after the disease progressed
Recurrence gene profiles in patients with different recurrence types (local /distant)	Time from first subject dose to study completion, or up to 36 month	To explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy