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NCT06570317

Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Recruiting now Last updated 26 August 2024
What this trial tests

trial testing Nintedanib in NSCLC in 40 participants. Currently enrolling.

Timeline
24 August 2024
Primary endpoint
31 May 2026
30 June 2026

Quick facts

Lead sponsorSecond Hospital of Shanxi Medical University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment40
Start date24 August 2024
Primary completion31 May 2026
Estimated completion30 June 2026
Sites7 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Hospital of Shanxi Medical University

Who can join

18 and older, any sex, with NSCLC or Nintedanib. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Nintedanib

Trials testing the same drug.

Other recruiting trials for NSCLC

Currently open trials in the same condition.

Other Second Hospital of Shanxi Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06570317.

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