Nintedanib
DrugFor patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy
NCT Number: NCT06570317
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Jincheng General Hospital, Jincheng, Shanxi, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy
Time frame: Up to 2 years
Incidence of adverse events
Time frame: Up to 2 years
Incidence of grade 2 and above radiation pneumonia
Time frame: Up to 2 years
Changes of pulmonary function indexes(FEV1, Dlco)
Time frame: Up to 2 years
From the date of enrollment to the date of disease progression
Time frame: Up to 2 years
From the date of enrollment until death by any cause or last follow-up
Contact information is provided by the study sponsor or research team.
Second Hospital of Shanxi Medical University
Other
Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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