Actively Recruiting
ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs
Led by Fudan University · Updated on 2026-03-11
53
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective study is to explore the safety and preliminary efficacy of stereotactic body radiotherapy (SBRT) combined with ORIENT-31 regimen (Sintilimab plus bevacizumab plus platinum-doublet chemotherapy) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients who failed first-line third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. Participants will first receive the standard four-drug combination therapy: PD-1 antibody + vascular endothelial growth factor (VEGF) antibody + platinum + pemetrexed. The efficacy will be evaluated every two courses. According to the efficacy evaluation results, personalized SBRT was be administered.
CONDITIONS
Official Title
ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status score of 0-1
- Histologically or cytologically confirmed stage IV primary non-small cell lung cancer
- EGFR-sensitive mutations (L858R, 19del)
- Resistance to first-line treatment with third-generation EGFR-TKIs
- At least one measurable lesion
- Patients with brain metastases must be asymptomatic neurologically and have stable lesions without systemic corticosteroid treatment
- Men and women of reproductive age agree to use contraception during the trial
- Life expectancy of at least 3 months
- Organ function within one week before enrollment meets specified blood, liver, and kidney function criteria
- Capacity to understand and voluntarily sign the informed consent form
You will not qualify if you...
- Severe autoimmune diseases such as active inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia
- Risk factors for intestinal perforation including active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal cancer
- History of other malignant tumors
- Active infections, heart failure, recent myocardial infarction within 6 months, unstable angina, or unstable arrhythmias
- Physical or laboratory conditions that may interfere with results or increase treatment risks
- Lesions requiring palliative radiation therapy
- Mixed small cell lung cancer components
- Nursing or pregnant women
- Immunodeficiency diseases including HIV, or history of organ or stem cell transplantation
- Known hepatitis B, hepatitis C, or active tuberculosis infection
- Received cancer vaccines or other vaccines within 4 weeks before treatment start (except seasonal influenza inactivated vaccines)
- Concurrent use of other immunotherapies, chemotherapy drugs, drugs from other clinical trials, or requiring long-term corticosteroid treatment
- Psychiatric disorders, substance abuse, or social issues affecting compliance
- Allergy or contraindication to PD-1 monoclonal antibodies, VEGF monoclonal antibodies, 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, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhengfei Zhu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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