Weekly low-dose oral vinorelbine plus PD-1 immunotherapy for older adults with advanced NSCLC
Official title: Effect and Safety of Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Patients With Non-small Cell Lung Cancer
Run by Anhui Chest Hospital · NCT07041320 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Anhui Chest Hospital Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | June 15, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT07041320 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Anhui Chest Hosptial
Hefei, Anhui, China Recruiting
Study contacts
- Principal investigator: Qingming Shi, Doctor — Anhui Chest Hosptial
- Study coordinator: Maojing Guan, Doctor
- Email: guanmaojing0623@126.com
- Phone: 021-0551-63773020
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Understanding what patients want from NSCLC treatment monitoring
Researchers are testing how patients with non-small cell lung cancer feel about and prefer monitoring their symptoms during treatment, with input from patients, caregivers, and clinicians.
-
PD-L1-targeted PET probe to map PD-L1 in solid tumors
A PET tracer called 18F-F-PDL1-3 is being tested to see if it can detect PD-L1 expression in primary and metastatic tumors to help guide personalized treatment.
-
Cardiorespiratory fitness after lobectomy versus sublobar resection in NSCLC
This study tests how different lung surgeries (lobectomy vs. sublobar resection) affect fitness levels after surgery in people with non-small cell lung cancer.
-
CAIX-targeted PET/CT imaging in solid tumors
Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.
-
Dignity Therapy for Older Adults in Long-Term Care
This study tests dignity therapy to help people 65 and older in long-term care see their lives as meaningful and preserve their sense of self.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.