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RECRUITING
NCT06570317

Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Sponsor: Second Hospital of Shanxi Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2024-08-24

Completion Date

2026-06-30

Last Updated

2024-08-26

Healthy Volunteers

No

Interventions

DRUG

Nintedanib

For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy

Locations (7)

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