Almonertinib Plus Metronomic Oral Vinorelbine

Fujian Provincial Cancer Hospital

Status: Not yet enrolling

Conditions: EGFR; Third-generation TKI; NSCLC

Treatments: Drug: Almonertinib and metronomic oral vinorelbine

Study type: Observational

Funder types: Other

Identifiers

NCT05663177

SCOG005

Details and patient eligibility

About

To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients.

Full description

This study is a clinical observation study. The patients who comfirm the criteria will be treated with Almonertinib plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated.

Drug administration regimen: Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-small cell lung cancer diagnosed by histopathology or cytology;
• Previous molecular pathology was EGFR sensitive mutation;
• Stage IV;
• ECOG score 0-2;
• Prior to receiving the third generation of EGFR-TKI targeted therapy, and TKI targeted therapy showed limited progress;
• According to RECIST1.1 standards, there are measurable or evaluable lesions
• The patient has fully understood this study and voluntarily signed a written informed consent form;
• The estimated survival time is more than 3 months.

Exclusion criteria

• Histological or cytological confirmation of small cell lung cancer or squamous cell carcinoma at the first diagnosis;
• The progression of the third generation EGFR-TKI suggests histological transformation.

Trial design

40 participants in 1 patient group

Study arm

Description:

Almonertinib plus metronomic oral vinorelbine

Treatment:

Drug: Almonertinib and metronomic oral vinorelbine