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Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

NCT06570317 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-08-26

No results posted yet for this study

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

Interventions

DRUG

Nintedanib

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

Sponsors & Collaborators

  • Second Hospital of Shanxi Medical University

    lead OTHER

Principal Investigators

  • Gang Jin, Dr. · Second Hospital of Shanxi Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-24
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06570317 on ClinicalTrials.gov