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Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Sponsor: Second Hospital of Shanxi Medical University
Summary
This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy. Primary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy. Patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.
Official title: Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2024-08-24
Completion Date
2026-06-30
Last Updated
2024-08-26
Healthy Volunteers
No
Conditions
Interventions
Nintedanib
For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy
Locations (7)
Jincheng General Hospital
Jincheng, Shanxi, China
Jinzhong third people's hospital
Jinzhong, Shanxi, China
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
TISCO General Hospital
Taiyuan, Shanxi, China