Almonertinib Plus Metronomic Oral Vinorelbine

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05663177
• Other study ID #: SCOG005
• Status: Not yet recruiting
• Start date: December 20, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2022
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• EGFR
• NSCLC

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR	Objective Response Rate	up to 12 months
Secondary	DCR	Disease Control Rate	up to 12 months