Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Elderly (People Aged 65 or More) | — | UNRESOLVED | — |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinor
- description
- 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.
Primary outcomes (1)
- measure
- objective response rate(ORR)
- timeFrame
- at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years
- description
- CR+PR/All patients(%)
Secondary outcomes (2)
- measure
- disease control rate (DCR)
- timeFrame
- at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years
- description
- CR+PR+SD/All patients(%)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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 treatedReferences
Publications (0)
Data not yet available