Advanced Non-small Cell Lung Cancer with Asymptomatic Brain Metastasis
Conditions
Interventions
Treatment group:PD-1/PD-L1 inhibitors with whole-brain radiotherapy
Control group:PD-1/PD-L1 inhibitors
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained; 2. Histologically/cytologically confirmed advanced/metastatic NSCLC patients without EGFR activating mutations or ALK translocation; Tumor PD-L1 expression >1%; 3. Enhanced MRI/CT confirmed brain metastasis, with at least =3 metastatic lesions; 4. Aged between 18 and 75 years old; 5. At least one measurable lesion as defined by RECIST 1.1 criteria; 6. Estimated life expectancy of at least 12 weeks; 7. ECOG PS 0-1; 8. Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) =1.5 x 10^9/L, platelets =100 x 10^9/L hemoglobin = 9 g/dL; Hepatic: total bilirubin =1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), alanine transaminase (ALT), and aspartate aminotransferase (AST) =3 times ULN (AP, ALT, and AST =5 times ULN may be included only if patient has liver metastasis); Renal: calculated creatinine clearance =45 mL/min (using the standard Cockcroft-Gault formula); 9. No prior history of malignant diseases, except for basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma, or cervical carcinoma in situ. Patients who are completely cured and have no recurrence within 5 years are eligible to this study; 10. Must compliant with a highly effective contraceptive method during the treatment period for fertile men and women.
Exclusion criteria
Exclusion criteria: 1. EGFR activating mutation or ALK translocation; 2. Patients who had received brain radiotherapy prior to enrollment; 3. Imaging or cerebralspinal fluid examination confirmed metastases of spinal cord, meninges, or meningeal; 4. Patients who take Phenytoin, Carbamazepine, Rifampin, Barbital, or St John's Wort which will interfere with the metabolism; 5. Patients with symptomatic brain metastasis, malignant meningitis, or spinal cord compression; 6. Patients with active autoimmune diseases within the past 2 years requiring systemic treatment with steroids or immunosuppressive agents; 7.Patients with lung interstitial inflammation or lung inflammation requiring treatment with steroids; 8. Any unstable systemic disease, including active infection, uncontrollable hypertension, unstable angina pectoris, congestive heart failure, and hepatic/renal or metabolic diseases; 9. History of HIV infection; 10. Patients with known active hepatitis B/C, or positive for HBsAg; or positive for active hepatitis C antigen; 11. Patients with mental disorders or history of drug abuse making compliance to the protocol improbable; 12. Positive pregnancy test, or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial PFS; | — |
Countries
China
Contacts
Public ContactXiaoxia Chen
Shanghai Pulmonary Hospital
Outcome results
None listed