Elderly (People Aged 65 or More), Lung Cancer (NSCLC)
Conditions
Keywords
Oral metronomic vinorelbine, PD-1 inhibitors
Brief summary
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.
Interventions
None listed
Sponsors
Anhui Chest Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) All patients are histologically or cytologically confirmed non-small cell lung cancer. Genetic testing identifies no driver gene mutations. 2\) Male or female, age ≥ 65 years 3) Patients had not received first-line treatment. 4) KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months; 5) No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results: 1. Blood routine test: Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L; 2. Blood biochemical test: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values; 3. 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.
Exclusion criteria
* previously treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate(ORR) | at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years | CR+PR/All patients(%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate (DCR) | at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years | CR+PR+SD/All patients(%) |
| progression-free survival (PFS) | at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years | PFS was calculated from treatment initiation to disease progression or death |
Countries
China
Contacts
Primary ContactMaojing Guan, Doctor
Outcome results
None listed