Clinical trial NCT06570317: Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Official title: Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Nintedanib
Radiation Pneumonitis
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: security
timeFrame: Up to 2 years
measure: Incidence rate of radiation pneumonia
timeFrame: Up to 2 years
Secondary outcomes:
measure: Pulmonary function index
timeFrame: Up to 2 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Jincheng
country: China
facility: Jincheng General Hospital
state: Shanxi
city: Jinzhong
country: China
facility: Jinzhong third people's hospital
state: Shanxi
city: Taiyuan
country: China
facility: Frist Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Hospital of Traditional Chinese Medicine
state: Shanxi
city: Taiyuan
country: China
facility: TISCO General Hospital
state: Shanxi
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: Gang Jin, Dr.
role: PRINCIPAL_INVESTIGATOR
References: