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

Hunan Province Tumor Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Osimertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06477055

2024-IIT0612

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Experimental group

Experimental group

Description:

All the patients were treated with osimertinib.

Treatment:

Drug: Osimertinib