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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Radiation Pneumonitis; Nintedanib
• Intervention / Treatment: Drug: Nintedanib

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Gang Jin, Dr.; Phone Number: +86 351 3365422; Email: jingang2018@sina.com
• Study Contact Backup: Name: Chen Zhang; Phone Number: +86 351 3365422

Study Locations

• China
  • Shanxi
    • Jincheng, Shanxi, China
      • Recruiting
      • Jincheng General Hospital
      • Contact: Xueqin Li, Dr.; Phone Number: +86 356 3661360
    • Jinzhong, Shanxi, China
      • Recruiting
      • Jinzhong third people's hospital
      • Contact: Qian Wu, Dr.; Phone Number: +86 354 3532157
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Huijing Feng, Dr.; Phone Number: +86 351 8368114
    • Taiyuan, Shanxi, China
      • Recruiting
      • Second Hospital of Shanxi Medical University
      • Contact: Gang Jin, Dr.; Phone Number: +86 351 3365422; Email: jingang2018@sina.com
    • Taiyuan, Shanxi, China
      • Recruiting
      • Frist Hospital of Shanxi Medical University
      • Contact: Dongwen Rong, Dr.; Phone Number: +86 13803491151
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Hospital of Traditional Chinese Medicine
      • Contact: Jinyang Bai, Dr.; Phone Number: +86 351 303009
    • Taiyuan, Shanxi, China
      • Recruiting
      • TISCO General Hospital
      • Contact: Weihua Jia, Dr.; Phone Number: +86 351 3012448

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

men or women over the age of 18 (including 18 years old), whose vital organs function well, who are diagnosed as non-small cell lung cancer by histology and cannot be surgically removed, and whose EGFR/ALK driver gene is negative by gene mutation test. The score of physical fitness in the Eastern Cooperative Oncology Group (ECOG) is 0 ~ 1, and the life expectancy is ≥3 months. At least one measurable lesion (non-brain) according to RECISTv1.1.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
security	Incidence of adverse events	Up to 2 years
Incidence rate of radiation pneumonia	Incidence of grade 2 and above radiation pneumonia	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	From the date of enrollment to the date of disease progression	Up to 2 years
Pulmonary function index	Changes of pulmonary function indexes（FEV1, Dlco）	Up to 2 years
Overall Survival (OS)	From the date of enrollment until death by any cause or last follow-up	Up to 2 years

Collaborators and Investigators

• Sponsor: Second Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Gang Jin, Dr., Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 24, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Pneumonia; Radiation Pneumonitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Nintedanib
• Other Study ID Numbers: [2024]YX No. 273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No