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A prospective, randomized, controlled, multicenter open clinical study on the efficacy and safety of nidanib in the prevention of post-radiotherapy lung injury in NSCLC

A prospective, randomized, controlled, multicenter open clinical study on the efficacy and safety of nidanib in the prevention of post-radiotherapy lung injury in NSCLC

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100845
Enrollment
Unknown
Registered
2025-04-16
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation lung injury after radiotherapy in NSCLC

Interventions

treatment group:On the basis of the conventional clinical treatment for the primary disease, the combined study drug was used. The study drug administration regimen was as follows: the study drug was
control group:Treatment of primary illnesses using conventional clinical protocols.

Sponsors

Zhangjiakou city first hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years at the time of screening; 2. Histologically/cytologically confirmed diagnosis of NSCLC; 3. TNM staging of stage II or III according to the International Association for the Study of Lung Cancerstaging manual (8th edition); 4. Unsuitable for or unable to tolerate surgery; 5. WHO performance status of 0 or 1 at randomization; 6. No previous radiation therapy; 7. Be able to swallow gelatin pills; 8. Suitable for completing pulmonary function tests; 9. Volunteered to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Expected life expectancy of <6 months at randomization; 2. Severe cardiovascular, cerebrovascular, neurological diseases, infections, epilepsy, active peptic ulcer, psychological disorders, etc.; 3. Abnormal liver function (transaminases elevated to 2.5 times or more the upper limit of normal); 4. Abnormal renal function (creatinine clearance <30 ml/min) or requiring dialysis; 5. Recent anticoagulation therapy or combination of deep vein thrombosis, pulmonary embolism, heart attack and cerebral infarction, etc.; 6. Antifibrotic therapy within 1 month; 7. Allergy or intolerance to therapeutic drugs and ingredients; 8. Pregnant or breastfeeding women; 9. Others who, in the judgement of the researcher, are not suitable to participate in the study

Design outcomes

Primary

MeasureTime frame
The incidence of grade 2 or higher RP;

Secondary

MeasureTime frame
The severity of RP;Therapeutic efficacy of RP;The effectiveness of tumor treatment;

Countries

China

Contacts

Public ContactCui Ai

Beijing Chaoyang Hospital, Capital Medical University

bj5453@sina.com+86 135 5288 7985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 5, 2026