Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAnhui Chest Hospital
About this trial
The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinorelbine and PD-1 inhibitors in elderly patients with unoperable, locally advanced or metastatic non-small-cell lung cancer. The primary end point was objective response rate (ORR), and the second end points included disease control rate (DCR), progression-free survival (PFS), and safety. Participants over 65 years old, received oral metronomic vinorelbine 40mg every week (20mg for patients over 80 years old), combined with PD-1 inhibitors every 3 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1) All patients are histologically or cytologically confirmed non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
Cardiac function test: 50% of the left ventricular ejection function of the heart >; 6) The subject has good compliance, and can cooperates with follow-up.
Disqualifiers
previously treated
Trial population
Patients over 65 years old with unoperable, locally advanced or metastatic non-small-cell lung cancer
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinor
Trial outcomes
Primary outcomes
1
objective response rate(ORR)
CR+PR/All patients(%)
Time frame
at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 yearsSecondary outcomes
1
disease control rate (DCR)
CR+PR+SD/All patients(%)
Time frame
at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years2
progression-free survival (PFS)
PFS was calculated from treatment initiation to disease progression or death
Time frame
at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov