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Trial Title:
Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC
NCT ID:
NCT06260553
Condition:
EGFR/ ALK-negative Advanced NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Tislelizumab
Vinorelbine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tislelizumab and metronomic oral vinorelbine
Description:
tislelizumab 200mg intravenous drip once every three weeks; Oral Vinorelbine 40mg three
times a week for three weeks and Q28d for one course.
Arm group label:
tislelizumab plus metronomic oral vinorelbine
Summary:
To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in
EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.
Detailed description:
This study is a clinical intervention study. The patients who comfirm the criteria will
be treated with tislelizumab 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: tislelizumab 200mg intravenous drip once
every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one
course.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or
M1b-American Joint Committee on Cancer [AJCC] 8th edition) squamous NSCLC or
non-squamous NSCLC without sensitising EGFR or ALK alterations.
- Has measurable disease based on RECIST 1.1 as determined by the local site
investigator/radiology assessment.
- Has not received prior systemic treatment for metastatic NSCLC.
- Has a life expectancy of at least 3 months.
- Has fully understood this study and voluntarily signed a written informed consent
form.
- Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to
poor performance status (ECOG performance status of 2-3)；>= 75 years of
age；substantial comorbidities; contraindication(s) for any platinum-doublet
chemotherapy.
Exclusion Criteria:
- Histological or cytological confirmation of small cell lung cancer.
- Has a known history of prior malignancy except if the participant has undergone
potentially curative therapy with no evidence of that disease recurrence for 5 years
since initiation of that therapy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Has disorders of oral medication.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian cancer hospital
Address:
City:
Fuzhou
Country:
China
Start date:
February 7, 2024
Completion date:
August 7, 2025
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06260553
