Almonertinib Plus Metronomic Oral Vinorelbine

Not yet recruiting

• Conditions: EGFR; Third-generation TKI; NSCLC
• Interventions: Drug: Almonertinib and metronomic oral vinorelbine

• Registration Number: NCT05663177
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-06
• Study Start: 2022-12-20
• Study First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23
• Primary Completion: 2023-12-20
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study arm	Almonertinib and metronomic oral vinorelbine	Almonertinib plus metronomic oral vinorelbine

Primary Outcome Measures

Name	Time	Method
PFS	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	progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	up to 12 months	Objective Response Rate
DCR	up to 12 months	Disease Control Rate