Actively Recruiting
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Led by Second Hospital of Shanxi Medical University · Updated on 2024-08-26
40
Participants Needed
7
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older when signing the consent form
- Confirmed diagnosis of unresectable non-small cell lung cancer with negative EGFR/ALK gene mutations
- At least one measurable lesion of 10 mm or larger confirmed by CT or MRI
- ECOG performance score of 0 to 1 within 3 days before treatment
- Life expectancy of 3 months or more
- Good function of vital organs
- Voluntary participation with signed consent and ability to comply with follow-up
You will not qualify if you...
- Severe respiratory diseases such as pulmonary fibrosis or active tuberculosis
- Mental disorders, blood diseases, autoimmune diseases, or serious heart, brain, liver, or kidney diseases
- Serious bleeding events requiring transfusion, intervention, or hospitalization within 3 months before treatment, or ongoing bleeding symptoms needing treatment
- Thrombosis, embolism, abnormal blood clotting, or bleeding tendencies
- Known or suspected allergy to the study drug or its ingredients
- Positive pregnancy test in pregnant, lactating, or fertile women
- Other factors judged by the researcher that could lead to early study termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Jincheng General Hospital
Jincheng, Shanxi, China
Actively Recruiting
2
Jinzhong third people's hospital
Jinzhong, Shanxi, China
Actively Recruiting
3
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Actively Recruiting
4
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Actively Recruiting
5
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
6
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
Actively Recruiting
7
TISCO General Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
G
Gang Jin, Dr.
CONTACT
C
Chen Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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