Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Non-small Cell Lung Cancer

Anhui Chest Hospital40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer (NSCLC)Elderly (People Aged 65 or More)

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 years

Secondary Outcomes

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 years

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 years

Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Non-small Cell Lung Cancer

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts