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Almonertinib Plus Metronomic Oral Vinorelbine

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05663177
Collaborator
(none)
40
Enrollment
17.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Almonertinib and metronomic oral vinorelbine

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC，an Observational Study
Anticipated Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Study arm

Almonertinib plus metronomic oral vinorelbine

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. ORR [up to 12 months]

    Objective Response Rate

  2. DCR [up to 12 months]

    Disease Control Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fujian Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05663177
Other Study ID Numbers:
  • SCOG005
First Posted:
Dec 23, 2022
Last Update Posted:
Dec 23, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vinorelbine

Study Results

No Results Posted as of Dec 23, 2022