NSCLCNCT06570317
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
An observational study of NSCLC and Nintedanib, run by Second Hospital of Shanxi Medical University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Nintedanib, Radiation Pneumonitis
- What is being tested?
- Nintedanib
- How many people
- 40 participants
- Where
- 7 sitesChina
- Study dates
- 24 Aug 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
Chen Zhang contact
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Jincheng General Hospital
Jincheng, Shanxi
Xueqin Li, Dr., +86 356 3661360
- Recruiting
Jinzhong third people's hospital
Jinzhong, Shanxi
Qian Wu, Dr., +86 354 3532157
- Recruiting
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi
Dongwen Rong, Dr., +86 13803491151
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Gang Jin, Dr., +86 351 3365422, jingang2018@sina.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Huijing Feng, Dr., +86 351 8368114
- Recruiting
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi
Jinyang Bai, Dr., +86 351 303009
- Recruiting
TISCO General Hospital
Taiyuan, Shanxi
Weihua Jia, Dr., +86 351 3012448
About this study
Official title: 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.
- Conditions
- NSCLC, Nintedanib, Radiation Pneumonitis
- Being tested
- Nintedanib
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
For patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
security
Incidence of adverse events
Measured: Up to 2 years
Incidence rate of radiation pneumonia
Incidence of grade 2 and above radiation pneumonia
Measured: Up to 2 years
Secondary outcomes (3)
Pulmonary function index
Changes of pulmonary function indexes（FEV1, Dlco）
Measured: Up to 2 years
Progression-free Survival (PFS)
From the date of enrollment to the date of disease progression
Measured: Up to 2 years
Overall Survival (OS)
From the date of enrollment until death by any cause or last follow-up
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start24 Aug 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Jin, Second Hospital of Shanxi Medical University
- Investigators
- Gang Jin, Dr., Principal investigator, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570317
- Sponsor's protocol ID
- [2024]YX No. 273
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
- ClinicalTrials.gov ID
- NCT06570317
- Acronym / sponsor ID
- [2024]YX No. 273
- Conditions
- NSCLC, Nintedanib, Radiation Pneumonitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 24 Aug 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibFor patients with unresectable NSCLC, nidanib is administered during sequential radiotherapy | Drug | – |
Primary outcome
security
Time frame: Up to 2 years
Incidence of adverse events
Incidence rate of radiation pneumonia
Time frame: Up to 2 years
Incidence of grade 2 and above radiation pneumonia
3 secondary outcomes
Pulmonary function index
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Zhang contact
Gang Jin, Dr. principal investigator
Second Hospital of Shanxi Medical University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and Nintedanib, run by Second Hospital of Shanxi Medical University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Jin, Dr. (+86 351 3365422, jingang2018@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
security (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.