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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05663177

Enrollment

Registered

2022-12-23

Start date

2022-12-20

Completion date

2024-06-01

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR, NSCLC, Third-generation TKI

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.

Interventions

DRUGAlmonertinib and metronomic oral vinorelbine

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026