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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinor

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.

No interventions assigned to this group

Eligibility Criteria

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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.