Clinical trial · Interventional
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
Study of Oral Vinorelbine Single Drug Concurrent Chemoradiotherapy and Immune-maintenance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer
NCT06540950CI-TRIAL-00079557unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vinorelbine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral vinorelbine concurrent radiotherapy group
- description
- All patients with unresectable stage III non-small cell lung cancer who received neoadjuvant chemo-immunotherapy received oral vinorelbine (60mg per square meter of body-surface area every 2 weeks before radiotherapy, and 30mg per square meter of body-surface area per week during radiotherapy) as radical concurrent chemoratherapy.
- interventionNames
- Drug: vinorelbine
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 5 years
- description
- The time between the start of treatment and death from any cause in the one-arm trial
- measure
- objective response rate
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥40 years old. 2. Patients must have histologically or cytologically confirmed non-small cell lung cancer. 3. ECOG PS was 0 or 1. 4. Adequate organ and bone marrow function is present. Absolute neutrophil counts, platelet counts, and hemoglobin criteria must not be met after blood transfusion or growth factor support within 14 days prior to randomization. Exclusion Criteria: 1. History of allogeneic organ transplantation. 2. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \[Colitis or Crohn's disease\], diverticulitis \[other than diverticulitis\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis\]). 3. There is uncontrolled serious underlying diseases, including active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease. 4. History of another primary malignancy. 5. History of active primary immunodeficiency. 6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer. 7. For any unmitigated toxicity during pre-study chemoradiotherapy. Patients who develop irreversible toxicity and are reasonably expected not to worsen after study treatment (such as hearing loss) may enter the study after consultation with the study physician. 8. Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy. 9. Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.
References
Publications (1)
- DERIVEDLian X, Shayan G, Yang S, Liu W, Zhang T, Lv J, Wang W, Wang J, Wang X, Xiao Z, Zhou Z, Bi N, Deng L. Efficacy and safety of oral vinorelbine with concurrent radiotherapy in unresectable stage III non-small cell lung cancer following neoadjuvant chemoimmunotherapy: a single-arm, phase 2 trial. J Natl Cancer Cent. 2025 Jul 21;5(6):593-599. doi: 10.1016/j.jncc.2025.06.004. eCollection 2025 Dec. PMID 41497257