Stage II-IIIb non-small cell lung cancer with sensitive EGFR mutations
Conditions
Interventions
Experimental group:BL-B01D1 plus Almonertinib
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and comply with the requirements of the protocol; 2. Gender is not limited; 3. Age at the time of signing the informed consent:>=18 years old and=50%; 9. The level of organ function must meet the following requirements and meet the following standards: a) Bone marrow function: absolute neutrophil count (ANC)>=1.5 × 10 ^ 9/L, platelet count>=100 × 10 ^ 9/L, hemoglobin>=90 g/L; b) Liver function: Total bilirubin TBIL=50 mL/min (according to the Cockcroft and Gault formula); d) Albumin>=30g/L. 10. Coagulation function: International normalized ratio (INR)<=1.5, and activated partial thromboplastin time (APTT)<=1.5 × ULN; 11. Urinary protein<=2+or<=1000mg/24h; 12. Female subjects with fertility or male subjects with fertility partners must start using highly effective contraception measures from 7 days before the first administration until 6 months after administration. Female subjects with fertility must have a negative serum pregnancy test within 7 days prior to the first administration.
Exclusion criteria
Exclusion criteria: 1.Patients who have received prior systemic or local antitumor therapy for non-small-cell lung cancer; 2.Patients with other malignant tumors within 5 years before the first administration, except those who have been cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are considered to be eligible for enrollment; 3.Major surgery (investigator-defined) within 4 weeks before the first dose; 4.Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases; 5.Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or serious infectious complications; 6.Patients at risk for active autoimmune disease, or with a history of autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome) and so on. Exceptions were type I diabetes, hypothyroidism that was stable with hormone-replacement therapy (including that due to autoimmune thyroid disease), psoriasis or vitiligo that did not require systemic therapy, and hypothyroidism that was stable with hormone-replacement therapy; 7.Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive and HBV-DNA copy number > central detection lower limit) or hepatitis C virus infection (HCV antibody positive and HCV-RNA > central detection lower limit); 8.Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg); 9.A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: a) severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, third degree atrioventricular block, complete left bundle branch block, frequent and uncontrollable arrhythmias, such as atrial fibrillation, atrial flutter, ventricular fibrillation, and ventricular flutter (except transient); b) prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women) at rest (except transient); c) acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose; d) patients with New York Heart Association (NYHA) functional class =II heart failure; e) unstable angina pectoris; f) patients with a history of cerebral infarction or cerebral hemorrhage within 6 months; 10.Previous history of allogeneic stem cell, bone marrow or organ transplantation; 11.Patients with a history of allergy to recombinant humanized antibodies or to BL-B01D1 or any excipients of almonertinib mesylate tablets; 12.A history of autologous or allogeneic stem cell transplantation; 13.Pregnant or lactating women; 14. Other circumstances considered by the investigator to be inappropriate for participation in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR;MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS);R0 resection rate;Objective Response Rate(ORR); | — |
Countries
China
Contacts
Public ContactWang Yongsheng/Liu Lunxu
West China Hospital of Sichuan University
Outcome results
None listed