Weekly low-dose oral vinorelbine plus PD-1 immunotherapy for older adults with advanced NSCLC

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

This project tries weekly low-dose oral vinorelbine together with PD‑1 immunotherapy to see if it helps people 65 and older with unresectable advanced non‑small cell lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Anhui Chest Hospital (Academic / other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07041320 on ClinicalTrials.gov

What this trial studies

This is an observational, single-center study of people aged 65 or older with histologically confirmed, treatment-naïve advanced or metastatic non‑small cell lung cancer lacking driver mutations. Participants received oral metronomic vinorelbine (40 mg weekly, reduced to 20 mg weekly for those over 80) combined with PD‑1 inhibitors given every three weeks. The primary outcome was objective response rate (ORR); secondary outcomes included disease control rate (DCR), progression-free survival (PFS), and safety. Patients were required to have good performance status (KPS ≥70 or ECOG 0–1) and adequate organ function prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates are people aged 65 or older with unresectable locally advanced or metastatic NSCLC without actionable driver mutations, who are treatment‑naïve for advanced disease, have KPS ≥70 (ECOG 0–1), and have adequate blood and organ function.

Not a fit: Patients with activating driver mutations, prior first-line therapy for advanced disease, poor performance status, or significant organ dysfunction are unlikely to gain benefit from this approach.

Why it matters

Potential benefit: If successful, the combination could provide a more tolerable, oral-based regimen that increases tumor responses and disease control in older patients who are less suited to standard chemotherapy.

How similar studies have performed: PD‑1 inhibitors have proven benefit in NSCLC and metronomic vinorelbine has shown tolerable activity in elderly patients, but combination data are limited and mostly from small or early-phase reports.

Eligibility criteria

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

Where this trial is running

Hefei, Anhui

• Anhui Chest Hosptial — Hefei, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Qingming Shi, Doctor — Anhui Chest Hosptial
• Study coordinator: Maojing Guan, Doctor

Conditions Lung Cancer; Elderly; Oral metronomic vinorelbine; PD-1 inhibitors