Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
NCT ID: NCT06570317
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2024-08-24
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Nintedanib
For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 2\) Non-small cell lung cancer was confirmed by histology and could not be resected, and EGFR/ALK driver gene was confirmed negative by gene mutation examination;
* 3\) At least one measurable lesion with imaging examination (according to RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the lesion are ≥ 10 mm;
* 4\) within 3 days before treatment, the score according to ECOG is 0 \~ 1;
* 5\) Life expectancy ≥3 months;
* 6)The vital organs function well,
* 7)The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.
Exclusion Criteria
* 2)Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;
* 3\) Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.);
* 4\) Thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency;
* 5\) Known or suspected to be allergic to the study drug and its auxiliary materials;
* 6\) The baseline pregnancy test of pregnant and lactating women or fertile women is positive.
* 7\) According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.
18 Years
ALL
No
Sponsors
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Second Hospital of Shanxi Medical University
OTHER
Responsible Party
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Gang Jin
Director
Principal Investigators
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Gang Jin, Dr.
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Locations
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Jincheng General Hospital
Jincheng, Shanxi, China
Jinzhong third people's hospital
Jinzhong, Shanxi, China
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
TISCO General Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Chen Zhang
Role: CONTACT
Facility Contacts
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Xueqin Li, Dr.
Role: primary
Qian Wu, Dr.
Role: primary
Dongwen Rong, Dr.
Role: primary
Huijing Feng, Dr.
Role: primary
Jinyang Bai, Dr.
Role: primary
Weihua Jia, Dr.
Role: primary
Other Identifiers
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[2024]YX No. 273
Identifier Type: -
Identifier Source: org_study_id
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