Almonertinib Plus Metronomic Oral Vinorelbine

NCT05663177 | Unknown

• 1 other identifier: SCOG005
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

EGFR; NSCLC; Third-generation TKI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ORR

  up to 12 months

• DCR

  up to 12 months

Study Arms (1)

Study arm

Almonertinib plus metronomic oral vinorelbine

Drug: Almonertinib and metronomic oral vinorelbine

Interventions

Almonertinib and metronomic oral vinorelbine DRUG

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

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Interventions

aumolertinib

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 23, 2022
• Study Start: December 20, 2022
• Primary Completion: December 20, 2023
• Study Completion: June 1, 2024
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share