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

NCT07041320 | Recruiting DMC

• 1 other identifier: Anhui Chest Hospital
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oral metronomic vinorelbine; PD-1 inhibitors

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR)

  CR+PR/All patients(%)

  at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years

Secondary Outcomes (2)

• disease control rate (DCR)

  at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years

• progression-free survival (PFS)

  at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 65 years old with unoperable, locally advanced or metastatic non-small-cell lung cancer

You may qualify if:

• \) All patients are histologically or cytologically confirmed non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
• \) 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:
• Blood routine test:
• Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L;
• 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;
• 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.

You may not qualify if:

• previously treated

Sponsors & Collaborators

• Anhui Chest Hospital: lead

Study Sites (1)

Anhui Chest Hosptial

Hefei, Anhui, 230022, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Qingming Shi, Doctor

  Anhui Chest Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maojing Guan, Doctor

CONTACT

021-0551-63773020; guanmaojing0623@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: June 27, 2025
• Study Start: June 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)