Status:
UNKNOWN
SBRT for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
NSCLC Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The treatment modality with immunotherapy has been the first-line standard treatment for advanced NSCLC. But more than 2/3 patients still develop acquired drug resistance within 5 years of immunothera...
Eligibility Criteria
Inclusion
- Age at least 18 years;
- ECOG PS 0-1;
- Patients with pathologically confirmed stage IV NSCLC by tumor biopsy and/or fine-needle aspiration （AJCC the 8th Edition）;
- Stable Disease for at least 6 months after first line immunotherapy;
- Oligoprogressive disease in 5 or fewer lesions and 3 or fewer organs;
- All oligopreogressive lesion ≤ 5cm, and intracranial lesion ≤3cm or 30cc;
- Progressive disease would be amenable to SBRT and without indications for palliative radiotherapy in the opinion of the investigator;
- Patients with a history of radiotherapy are eligible if radiotherapy administered more than 4 weeks before study entry;
- Adequate organ function prior to enrollment:
- Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L and hemoglobin ≥90g/L,; Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN;
- Life expectancy of more than 3 months;
- Ability to understand and willingness to provide the informed consent and signed informed consent for the use of fresh tumor biopsies before and during the treatment;
- Women of childbearing age and men must agree to use effective contraception during the trial.
Exclusion
- History of another malignancy or concurrent malignancy (except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non-invasive bladder cancer, cervical cancer in situ);
- Positive for driver genes including EGFR, ALK, and ROS-1;
- Mixed small cell with non-small cell lung cancer histology;
- Malignant pleural or ascites;
- Patients with brain metastasis require intracranial decompression;
- Symptoms of spinal cord compression;
- Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides;
- Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.
- History of another malignancy or concurrent malignancy;
- Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment;
- The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding;
- Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05387044
Start Date
May 1 2022
End Date
April 30 2024
Last Update
May 24 2022
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022