non-small cell lung cancer
Conditions
Interventions
Intervention group:All enrolled patients received 2 cycles (42 days) of neoadjuvant befotertinib in combination with vorolanib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old (including 18 and 75 years old); (2) Clinically confirmed as non-small cell lung cancer by histopathology, and confirmed to carry EGFR gene 19 and/or exon 21 sensitive mutations by tissue or blood genetic testing; Patients with mixed NSCLC histologic features (squamous and non-squamous) or not clearly stated NSCLC may be enrolled; (3) According to the 8th edition of the AJCC staging system, the clinical stage was stage II-IIIB, and all lesions were evaluated to be operationally curatively resected; (4) ECOG behavioral status score of 0~1, expected survival time >1 year; (5) The functional level of important organs such as heart, lungs, liver, and kidneys meets the requirements of research drugs and anesthesia surgery. Subjects must meet the following laboratory indicators: absolute neutrophil value (ANC) >=1.5x10^9/L; platelets 100×10^9/L; hemoglobin >9 g/dL; Total bilirubin = 60 ml/min; Good coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (6) Females of childbearing potential must have a negative pregnancy test within 7 days before starting treatment, and use contraception during and within 3 months after the end of treatment; Males of childbearing age: use contraception during surgical sterilization or treatment and for 3 months after the end of treatment; (7) At least one measurable lesion as assessed by the investigator according to RECIST version 1.1; (8) Understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not eligible to participate in this study: (1) The pathological type is small cell lung cancer, or mixed type lung cancer containing small cell lung cancer, or large cell neuroendocrine carcinoma or sarcomatoid carcinoma. (2) Anticipated to be surgically unresectable or only potentially resectable. (3) The patient has obvious hemoptysis, or the risk of bleeding is assessed to be greater. (4) Received any systemic anti-tumor therapy in this study, including chemotherapy, radiotherapy, immunotherapy (including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs acting on another co-inhibitory T cell receptor) or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.); (5) The patient has been diagnosed with other malignant tumors in the past; (6) Prior interstitial lung disease, drug-induced interstitial disease, or any active interstitial lung disease with clinical evidence; Idiopathic pulmonary fibrosis on CT scan at baseline; (7) Evidence of severe or uncontrollable systemic disease (such as unstable or uncompensatory respiratory, cardiac, hepatic or renal disease) as judged by the investigator; (8) Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, congestive heart failure, hepatorenal or metabolic disease); (9) Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia; (10) Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection; (11) Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or some other infectious diseases deemed inappropriate for enrollment; (12) Known severe allergy to the study drug and/or any of its excipients; (13) Pregnant or lactating women; (14) Other situations that the investigator believes cannot be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;RP2D;Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate;Objective response rate;R0 surgical resection rate;Disease control rate;Disease-free survival after surgery;Overall survival; | — |
Countries
China
Contacts
Public ContactJian Zeng
Zhejiang Cancer Hospital
Outcome results
None listed