Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Shanxi Medical University

Status: Enrolling

Conditions: Nintedanib; Radiation Pneumonitis; NSCLC

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Other

Identifiers

NCT06570317

[2024]YX No. 273

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.