Almonertinib Plus Metronomic Oral Vinorelbine

Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC，an Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC; EGFR; Third-generation TKI
• Intervention / Treatment: Drug: Almonertinib and metronomic oral vinorelbine

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 Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

EGFR-mutant advanced NSCLC, disease progression on the third-generation TKI

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study arm; Almonertinib plus metronomic oral vinorelbine	Drug: Almonertinib and metronomic oral vinorelbine; Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	up to 12 months
DCR	Disease Control Rate	up to 12 months

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Estimate): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: SCOG005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No