RecruitingNCT07041320

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


Sponsor

Anhui Chest Hospital

Enrollment

40 participants

Start Date

Jun 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of oral vinorelbine (a chemotherapy pill taken in low, frequent doses, called "metronomic" dosing) together with a PD-1 inhibitor (a type of immunotherapy) for older patients with non-small cell lung cancer (NSCLC) who have no specific gene mutations. This approach may be gentler than standard chemotherapy while still being effective in elderly patients. **You may be eligible if...** - You are 65 years of age or older - You have been confirmed to have non-small cell lung cancer without specific driver gene mutations (such as EGFR or ALK) - You have not yet received any first-line treatment for lung cancer - You are in reasonably good physical condition (KPS ≥70 or ECOG 0–1) - Your expected survival is at least 3 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have already received first-line treatment for this cancer - You have serious organ dysfunction - You have active infections or uncontrolled medical conditions - You have certain driver gene mutations that would call for different targeted therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Anhui Chest Hosptial

Hefei, Anhui, China

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NCT07041320


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