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Trial Title:
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
NCT ID:
NCT06540950
Condition:
Vinorelbine
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Vinorelbine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
vinorelbine
Description:
Vinorelbine is administered orally at 60mg per square meter per week by body surface area
before radiotherapy and continued to be administered at 30mg per square meter per week
during radiotherapy until the end of radiotherapy. Within 6 weeks after the end of
radiotherapy, there are no serious side effects, and immune checkpoint inhibitors
monotherapy can be performed.
Arm group label:
Oral vinorelbine concurrent radiotherapy group
Other name:
oral vinorelbine concurrent chemoradiotherapy
Summary:
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.
Detailed description:
Patients with unresectable stage III non-small cell lung cancer after neoadjuvant
chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral
vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response
rate, and secondary endpoints include disease control rate, progression-free survival,
compliance and safety.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
March 20, 2023
Completion date:
June 10, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540950
