Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Vinorelbine
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief 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 neoad...
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...
Eligibility Criteria
Inclusion
- Age ≥40 years old.
- Patients must have histologically or cytologically confirmed non-small cell lung cancer.
- ECOG PS was 0 or 1.
- 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
- History of allogeneic organ transplantation.
- 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 \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis\]).
- 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.
- History of another primary malignancy.
- History of active primary immunodeficiency.
- Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
- 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.
- Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy.
- Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.
Key Trial Info
Start Date :
March 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2026
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06540950
Start Date
March 20 2023
End Date
June 10 2026
Last Update
August 7 2024
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021