Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Recruiting

• Conditions: NSCLC; Nintedanib; Radiation Pneumonitis

• Registration Number: NCT06570317
• Lead Sponsor: Second Hospital of Shanxi Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> - <br><br> 1) Men or women who are over 18 years old (including 18 years old) when signing<br> the informed consent form;<br><br> - <br><br> 2) Non-small cell lung cancer was confirmed by histology and could not be<br> resected, and EGFR/ALK driver gene was confirmed negative by gene mutation<br> examination;<br><br> - <br><br> 3) At least one measurable lesion with imaging examination (according to<br> RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the<br> lesion are = 10 mm;<br><br> - <br><br> 4) within 3 days before treatment, the score according to ECOG is 0 ~ 1;<br><br> - <br><br> 5) Life expectancy =3 months;<br><br> - 6)The vital organs function well,<br><br> - 7)The subjects volunteered to join the study and signed the informed consent form,<br> with good compliance and cooperation with the follow-up.<br><br>Exclusion Criteria:<br><br> - <br><br> 1) Complicated with severe respiratory diseases: pulmonary fibrosis, active<br> tuberculosis, etc.<br><br> - 2)Persons with mental disorder, blood system diseases, autoimmune diseases and<br> serious primary diseases of heart, brain, liver and kidney;<br><br> - <br><br> 3) Hemorrhagic events that require blood transfusion, invasive intervention or<br> hospitalization occur within 3 months before the first administration, or there<br> are bleeding symptoms and need intervention treatment (such as hemoptysis,<br> hematuria and bloody stool), or high-risk factors with bleeding risk (such as<br> tumor surrounding or invading important blood vessels, obvious necrosis or<br> cavity around tumor, esophageal varices, etc.);<br><br> - <br><br> 4) Thrombosis or embolic diseases, abnormal blood coagulation function and<br> bleeding tendency;<br><br> - <br><br> 5) Known or suspected to be allergic to the study drug and its auxiliary<br> materials;<br><br> - <br><br> 6) The baseline pregnancy test of pregnant and lactating women or fertile women is<br> positive.<br><br> - <br><br> 7) According to the researcher's judgment, the subjects have other factors that<br> may lead to the forced termination of this study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
security;Incidence rate of radiation pneumonia

Secondary Outcome Measures

Name	Time	Method
Pulmonary function index;Progression-free Survival (PFS);Overall Survival (OS)