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Prospective, Multicentre Phase II Clinical Study of 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study patients with unresectable non-small cell lung cancer (NSCLC) who receive nintedanib alongside sequential radiotherapy. The study evaluates the occurrence of significant radiation pneumonitis (above grade 2) and monitors the safety of combining nintedanib with radiotherapy. Additionally, the study will observe progression-free survival (PFS) and overall survival (OS) in patients treated with nintedanib plus radiotherapy and immunotherapy. Participants will first undergo induction therapy, including chemotherapy and/or immunotherapy for at least one cycle. Following this, they will receive sequential radiotherapy combined with nintedanib treatment for six months. After completing this phase, patients will continue with maintenance immunotherapy for 16 cycles as part of their treatment plan. Throughout the study, participants will be monitored for safety and the incidence of radiation pneumonia for up to two years. Lung function, PFS, and OS will also be assessed during this period. The total follow-up and observation will last up to two years to evaluate these outcomes and monitor patient health comprehensively.
CONDITIONS
Brief 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 at the time of consent
- Confirmed diagnosis of unresectable non-small cell lung cancer by histology
- Negative for EGFR and ALK gene mutations
- At least one measurable lesion of 10 mm or larger by spiral CT or MR
- ECOG performance score of 0 to 1 within 3 days before treatment
- Life expectancy of 3 months or more
- Good function of vital organs
- Willingness to participate and sign informed consent with good compliance and follow-up cooperation
You will not qualify if you...
- Severe respiratory diseases such as pulmonary fibrosis or active tuberculosis
- Mental disorders, blood system diseases, autoimmune diseases, or serious heart, brain, liver, or kidney diseases
- Recent hemorrhagic events requiring blood transfusion, invasive treatment, or hospitalization within 3 months before first administration
- Presence of bleeding symptoms requiring intervention or high-risk bleeding factors
- Thrombosis, embolism, abnormal blood coagulation, or bleeding tendency
- Known or suspected allergy to nintedanib or its components
- Positive baseline pregnancy test for pregnant, lactating, or fertile women
- Other conditions judged by researchers to require study termination
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During sequential radiotherapy
Participants receive nintedanib during sequential radiotherapy to prevent radiation pneumonia.
Visits as per radiotherapy schedule
Duration - Up to 2 years
Participants are monitored for up to 2 years for safety, incidence of radiation pneumonia, pulmonary function, and survival outcomes.
Follow-up visits over 2 years
Trial Site Locations
Total: 7 locations
1
Jincheng General Hospital
Jincheng, Shanxi, China
Actively Recruiting
2
Jinzhong third people's hospital
Jinzhong, Shanxi, China
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3
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
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4
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
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5
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
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6
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
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7
TISCO General Hospital
Taiyuan, Shanxi, China
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Research Team
G
Gang Jin, Dr.
C
Chen Zhang
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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