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Almonertinib Plus Metronomic Oral Vinorelbine

NCT ID: NCT05663177

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-20

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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EGFR NSCLC Third-generation TKI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study arm

Almonertinib plus metronomic oral vinorelbine

Almonertinib and metronomic oral vinorelbine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SCOG005

Identifier Type: -

Identifier Source: org_study_id