NCT06570317 Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
| NCT ID | NCT06570317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Hospital of Shanxi Medical University |
| Condition | NSCLC |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-24 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-08-24 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 1\) Men or women who are over 18 years old (including 18 years old) when signing the informed consent form; * 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: * 1\) Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc. * 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.
Contact & Investigator
Gang Jin, Dr.
PRINCIPAL INVESTIGATOR
Second Hospital of Shanxi Medical University
Frequently Asked Questions
Who can join the NCT06570317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06570317 currently recruiting?
Yes, NCT06570317 is actively recruiting participants. Contact the research team at jingang2018@sina.com for enrollment information.
Where is the NCT06570317 trial being conducted?
This trial is being conducted at Jincheng, China, Jinzhong, China, Taiyuan, China, Taiyuan, China and 3 additional locations.
Who is sponsoring the NCT06570317 clinical trial?
NCT06570317 is sponsored by Second Hospital of Shanxi Medical University. The principal investigator is Gang Jin, Dr. at Second Hospital of Shanxi Medical University. The trial plans to enroll 40 participants.