Almonertinib Plus Metronomic Oral Vinorelbine

Fujian Cancer Hospital40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

EGFR NSCLC Third-generation TKI

Interventions

Almonertinib and metronomic oral vinorelbineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PFS

progression-free survival

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes

ORR

Objective Response Rate

Time frame: up to 12 months

DCR

Disease Control Rate

Time frame: up to 12 months

Data from ClinicalTrials.gov

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