Status:
UNKNOWN
SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC
Lead Sponsor:
Fudan University
Conditions:
NSCLC Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is an open-label, multicenter, phase II single arm trial to evaluate the efficacy and safety of SBRT in combination with sintilimab and GM-CSF for the treatment of patients with advanced NS...
Eligibility Criteria
Inclusion
- Age at least 18 years.
- ECOG PS 0-1.
- Pathologically confirmed stage IV NSCLC.
- Negative for driver genes including EGFR，ALK，and ROS-1.
- Patients with disease progression after first-line platinum-based therapy without anti-PD-1 or PD-L1 treatment.
- Patients with at least one lesion (size 1-5cm) eligible for SBRT (24Gy/3Fx) and simultaneously at least one measurable lesion (in addition to the lesion treated with SBRT) as defined by RECIST1.1.
- Patients with brain metastasis are eligible if they are asymptomatic, neurologically stable, and off corticosteroids.
- Life expectancy of more than 3 months.
- Patients with no indications for palliative radiotherapy in the opinion of the investigator.
- Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
- 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.
- Adequate organ function within 1 week prior to the enrollment：
- Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;
- Adequate hepatic function: total bilirubin \< 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
- Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;
- Ability to understand and willingness to provide the informed consent.
Exclusion
- Prior exposure to immunomodulatory agent,including but limited to anti-PD-1 or anti-PD-L1 antibodies.
- 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.
- Patients receiving non-platinum-based chemotherapy as first-line treatment
- Mixed small cell with non-small cell lung cancer histology.
- Pregnant or lactating women.
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis.
- History of any other malignancy.
- Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
- Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
- Prior allergic reaction or contraindications to sintilimab and GM-CSF.
- Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment. Note: Influenza vaccination is permitted only during influenza season, while live, attenuated influenza vaccine such as FluMist is not allowed.
- Patients receiving concurrent chemotherapy drugs,other immunosuppressive agents,or other investigational treatment.Long-term corticosteroid users are also excluded.
- Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04106180
Start Date
September 30 2019
End Date
August 31 2023
Last Update
September 26 2019
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China