NCT06570317

Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Second Hospital of Shanxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC
• Nintedanib
• Radiation Pneumonitis

Interventions

Type	Name	Description
DRUG	Nintedanib	For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy

Timeline

• Start date: 2024-08-24
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

7 sites across 1 country: China