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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

NCT05663177•Fujian Cancer Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Key Dates

Start Date

December 20, 2022

Primary Completion Date

December 20, 2023

Completion Date

June 1, 2024

Last Updated

December 23, 2022

Enrollment

ESTIMATED participants

Conditions

EGFRNSCLCThird-generation TKI

Interventions

Almonertinib and metronomic oral vinorelbine

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITING

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

View study

RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Almonertinib Plus Metronomic Oral Vinorelbine

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Magnetic Resonance Imaging of the Lung: Oncological Applications

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed