Actively Recruiting
Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
Led by Fudan University · Updated on 2024-06-05
146
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC
CONDITIONS
Official Title
Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG functional status score of 0-1
- Histologically confirmed stage IV primary NSCLC
- Negative genetic tests for common driver genes including EGFR, ALK, and ROS-1
- Patients with neurologically asymptomatic and stable brain metastases without systemic glucocorticoids
- No current need for palliative radiotherapy as judged by the investigator
- Male or female of childbearing potential agrees to use contraception during the trial
- Life expectancy of 3 months or more
- Organ function within specified limits one week before enrollment including bone marrow, liver, kidney, and serum albumin levels
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Severe autoimmune diseases such as active inflammatory bowel disease, rheumatoid arthritis, scleroderma, lupus, or autoimmune vasculitis
- Symptomatic interstitial lung disease or active pneumonia
- Risk factors for intestinal perforation including active diverticulitis or gastrointestinal obstruction
- History of other malignant tumors
- Active infection, heart failure, recent myocardial infarction, unstable angina, or unstable arrhythmia within past 6 months
- Conditions that may interfere with study results or increase treatment risks as judged by investigator
- Lesions requiring palliative or subtractive radiotherapy
- Mixed small cell lung cancer components
- Pregnant or lactating women
- Congenital or acquired immunodeficiency including HIV, organ transplantation, or stem cell transplantation
- Known hepatitis B or C, or active pulmonary tuberculosis
- Recent cancer vaccine or other vaccine within 4 weeks before treatment (except injectable seasonal influenza vaccine)
- Concurrent use of other immune agents, chemotherapy drugs, clinical study drugs, or long-term corticosteroids
- Mental disorders, substance abuse, or social problems affecting adherence
- Allergy or contraindication to PD-1 monoclonal antibody or chemotherapy drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhengfei Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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