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Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITING

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

Effect and Safety of Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Patients With Non-small Cell Lung Cancer

NCT07041320•Anhui Chest Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Anhui Chest Hosptial

Hefei, Anhui, China

Key Dates

Start Date

June 15, 2023

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

June 27, 2025

Enrollment

ESTIMATED participants

Conditions

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

Contacts

Maojing Guan, Doctor

CONTACT

021-0551-63773020 guanmaojing0623@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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