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.
Study Type
OBSERVATIONAL
Enrollment
40
For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy
Jincheng General Hospital
Jincheng, Shanxi, China
RECRUITINGJinzhong third people's hospital
Jinzhong, Shanxi, China
RECRUITINGFrist Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
RECRUITINGSecond Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
RECRUITINGShanxi Bethune Hospital
Taiyuan, Shanxi, China
RECRUITINGShanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
RECRUITINGTISCO General Hospital
Taiyuan, Shanxi, China
RECRUITINGsecurity
Incidence of adverse events
Time frame: Up to 2 years
Incidence rate of radiation pneumonia
Incidence of grade 2 and above radiation pneumonia
Time frame: Up to 2 years
Pulmonary function index
Changes of pulmonary function indexes(FEV1, Dlco)
Time frame: Up to 2 years
Progression-free Survival (PFS)
From the date of enrollment to the date of disease progression
Time frame: Up to 2 years
Overall Survival (OS)
From the date of enrollment until death by any cause or last follow-up
Time frame: Up to 2 years
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