Using nintedanib to prevent radiation pneumonia in patients with unresectable lung cancer

Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

This study tests if the drug nintedanib can help prevent radiation pneumonia in patients with advanced lung cancer who are receiving radiation therapy.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Hospital of Shanxi Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 7 sites (Jincheng, Shanxi and 6 other locations)
• Trial ID: NCT06570317 on ClinicalTrials.gov

What this trial studies

This observational study investigates the safety and efficacy of nintedanib in patients with unresectable non-small cell lung cancer (NSCLC) undergoing sequential radiotherapy. Participants will receive nintedanib alongside radiotherapy for six months after completing induction therapy, chemotherapy, and/or immunotherapy. The study aims to evaluate the incidence of radiation pneumonitis above grade 2, as well as assess progression-free survival (PFS) and overall survival (OS) outcomes. The study will also monitor changes in lung function during the treatment period.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with unresectable NSCLC who have completed at least one cycle of induction therapy and have no severe respiratory diseases.

Not a fit: Patients with severe respiratory diseases, mental disorders, or serious primary diseases affecting vital organs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the incidence of radiation pneumonitis and improve survival outcomes for patients with unresectable NSCLC.

How similar studies have performed: While there have been studies on nintedanib and lung cancer, this specific combination with sequential radiotherapy is novel and has not been extensively tested.

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.

Where this trial is running

Jincheng, Shanxi and 6 other locations

• Jincheng General Hospital — Jincheng, Shanxi, China (Recruiting)
• Jinzhong third people's hospital — Jinzhong, Shanxi, China (Recruiting)
• Frist Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Second Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• Shanxi Hospital of Traditional Chinese Medicine — Taiyuan, Shanxi, China (Recruiting)
• TISCO General Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Gang Jin, Dr. — Second Hospital of Shanxi Medical University
• Study coordinator: Gang Jin, Dr.

Conditions NSCLC; Nintedanib; Radiation Pneumonitis