non-small-cell lung cancer
Conditions
Interventions
Cohort 1 and 2:Cohort 1: Furmonertinib 80mg orally once a day + Toripalimab 240mg intravenously every 3 weeks.
Cohort 2:Cohort 2: Induction therapy with 80mg of Furmonertinib in first 8 weeks, sequential oral administration of Furmonertinib 80mg once a day + Toripalimab 240mg intravenously every 3 weeks.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, regardless of gender; 2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC who are not candidates for radical surgery or radiotherapy; 3. Confirmed as EGFR sensitive mutation (19 Del or 21 L858R); 4. PD-L1 TPS >= 1%; 5. ECOG PS 0-1 points; 6. At least 1 measurable lesion per RECIST v1.1 as determined by the investigator; 7. Expected survival time >= 3 months; 8. The main organ function is normal (14 days before enrollment); Neutrophils >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90g/L; Blood creatinine =50mL/min; Serum total bilirubin <=1.5×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5×ULN. For patients with liver metastasis, ALT and AST<=5×ULN. The International normalized ratio (INR) or prothrombin time (PT) should be <=1.5×ULN unless the subject is undergoing anticoagulant therapy. The activated partial thrombin time (aPTT) should be <=1.5×ULN unless the subject is undergoing anticoagulant therapy Treatment; 9. The subject or legal representative has been informed of the nature of the study, understands the provisions in the protocol, is able to ensure compliance, and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals who are known to be allergic to recombinant humanized anti PD-1 monoclonal antibody drugs and their components; 2. Individuals who are known to be allergic to furmonertinib and its components; 3. Tumor histology or cytological pathology confirms the presence of small cell lung cancer components or sarcomatoid carcinoma lesions; 4. Currently participating in and receiving other research and treatment; 5. Previously received systematic treatment for advanced NSCLC, including systemic chemotherapy, targeted therapy, immunotherapy, etc; 6. Within 6 months prior to receiving study treatment, patients received > 30Gy of chest (lung) radiation therapy, except for local palliative radiotherapy for bone metastases; 7. Have received traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or have undergone major surgery within 4 weeks before the first administration or have not yet fully recovered from previous surgery; 8. Patients with active pulmonary tuberculosis (TB) who are currently receiving anti-tuberculosis treatment or have received anti tuberculosis treatment within one year prior to screening; 9. Active or untreated central nervous system (CNS) tumor metastasis; 10. Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage (once a month or more frequently), with stable symptoms after drainage for at least two weeks, can be included in the group; 11. Uncontrolled or symptomatic hypercalcemia (> 1.5mmol/L calcium ions or calcium > 12mg/dL or corrected serum calcium > ULN); 12. There are uncontrolled active infections in clinical practice, including but not limited to acute pneumonia; 13. Uncontrolled major seizures or superior vena cava syndrome; 14. Other malignant tumors have occurred or are currently suffering at the same time within 5 years (except for non melanoma skin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma in situ, superficial bladder cancer, or other tumors with low malignancy and receiving radical anti-tumor treatment, which is judged by the researcher); 15. Having a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia found during chest CT scan screening, or other moderate to severe lung diseases that seriously affect lung function; 16. Known clinically significant liver diseases, including untreated active viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, and hereditary liver diseases; 17. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 18. Having severe cardiovascular diseases, such as NYHA grade 2 or above heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident occurring within 6 months prior to enrollment; 19. Within 2 years prior to the start of the study, systemic immunosuppressive drugs (i.e. corticosteroids or immunosuppressive drugs) were received due to any active autoimmune disease; 20. Received live virus vaccine within 4 weeks before the start of the study; 21. Patients who have previously received allogeneic stem cell or parenchymal organ transplantation; 22. Pregnant or lactating women, or women with the possibility of pregnancy, w
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of Response; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactWeimin Li
West China Hospital, Sichuan University
Outcome results
None listed