lung cancer
Conditions
Interventions
Case series:Toripalimab with Anlotinib
Sponsors
cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histological confirmed EGFR mutation-positive stage IV non-small cell lung cancer patients with progression after receiving first- or second-generation EGFR-TKI as first-line treatment, histological or cytologically confirmed T790M-negative. Histological confirmed EGFR mutation-positive stage IV non-small cell lung cancer patients with progression after receiving third-generation EGFR-TKI as first- or second-line treatment; 2. According to the RECIST 1.1 standard, there is at least one measurable target lesion. All lesions should be evaluated within 4 weeks before the start of the study; 3. Patients who are unwilling to receive chemotherapy or cannot tolerate chemotherapy; 4. ECOG physical score 0-2 points; 5. Patients may have a history of brain or meningeal metastasis. If symptoms are presented, local treatment (surgery and/or radiotherapy) should be done before enrollment, and there is no further plan of treatment after enrollment. 6. Aged >=18 years old; 7. Expected survival time >=12 weeks; 8. Patients are capable of taking medicine orally; 9. The results of the serum pregnancy test of women of childbearing age must be negative within 7 days before treatment; 10. Women of childbearing age should agree to take adequate barrier contraception during and within 4 weeks after the study; 11. The main organ function meets the following criteria within 7 days before treatment: (1) Aspartate aminotransferase and alanine aminotransferase =1.5x10^9/L; (4) Platelets >=80x10^9/L; (5) Hemoglobin >=80 g/L; (6) Creatinine clearance rate >=50ml/min (According to the Cockroft-Gault formula); 12. Patients must have the ability to understand and sign informed consent voluntarily, which must be done before any experimental process.
Exclusion criteria
Exclusion criteria: 1. History of cardiovascular system: (1) Any of the following events occurred within 12 months before the start of medication: unstable angina, myocardial infarction, coronary artery bypass grafting, congestive heart failure with symptoms, cerebrovascular accident (including transient ischemic attack), pulmonary embolism, severe mitral stenosis; (2) NCI-CTCAE >=grade 2 arrhythmia, atrial fibrillation QT or interval prolongation of any NCI-CTCAE grade (male > 45mm, female > 47mm); (3) Uncontrollable hypertension treated with two or more antihypertensive drugs (> 150/90mmHg after rational medication); 2. History or respiratory system: Any of the following events occurred within 12 months before the start of medication: bronchiectasis, COPD, pulmonary abscess; 3. History of HIV infection; 4. History of allogeneic organ transplantation; 5. Active or uncontrolled serious infections (NCI-CTCAE > grade 2); 6. Epilepsy which needs drug treatment; 7. Patients requiring renal dialysis; 8. Patients with a bleeding tendency or coagulation disorder; 9. CTCAE >=grade 2 pulmonary hemorrhage occurred within 4 weeks before the start of medication; 10. CTCAE >=grade 3 bleeding (excluding pulmonary hemorrhage) occurred within 4 weeks before the start of medication. 11. Wound, ulcer or fracture which is not healing for a long time; 12. Arteriovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, pulmonary embolism, etc. within 6 months before the start of medication; 13. Patients suffering from NSCLC and other tumors at the same time, have no previous treating experience of other tumors; 14. The presence of medicine abuse. Patients with medical, psychological or social conditions that may interfere with their decision of participation or evaluation of results; 15. Patients who stop taking EGFR-TKI due to intolerable adverse events; 16. Presence of any disease affecting the evaluation of the study; 17. Any conditions that may endanger the safety of patients and their compliance with the study; 18. Any conditions that affect the intake, transport or absorption of drugs, including any kind of gastrointestinal resection or other operation histories.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress free survival;disease control rate;safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactWang Yan
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed