Non-small cell lung cancer, NSCLC
Conditions
Interventions
Single drug group:Limertinib
Combination group:Limertinib+Bevacizumab
Sponsors
Anhui Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Qualified participants for this study must meet all of the following criteria: 1. Sign written informed consent before implementing any experimental procedures; 2. Age >= 18 years old; 3. Non squamous non-small cell lung cancer confirmed by histology or cytology; According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification, 9th edition TNM, patients with locally advanced stage (IIIB-IIIC), metastatic or recurrent (stage IV) lung cancer staging are not suitable for treatment through surgery or radiation therapy; 5. Confirmed EGFR mutation positive by tumor histology, cytology, or hematology, with no other target mutations/fusions/amplifications 6. Progress in previous first-line third-generation EGFR-TKI treatments (Axitinib, Fumatinib, Amitinib, etc.) 7. No previous treatment with anti angiogenic drugs 8. ECOG score 0-1 points; According to the criteria for evaluating the efficacy of solid tumors (RECIST v1.1 version), there should be at least one measurable lesion on imaging. If the lesion located within the previous radiation field is confirmed to have progressed, it can be considered a measurable lesion; 10. Subjects with brain metastases who are asymptomatic or have stable symptoms after local treatment are allowed to be enrolled, as long as they meet the following conditions: 1) Measurable lesions outside the central nervous system 2) No central nervous system symptoms or no worsening of symptoms within at least 2 weeks; 3) No need for glucocorticoid treatment, or discontinuation of glucocorticoid treatment within 7 days prior to the first dose, or stable and reduced glucocorticoid dosage to below 10mg/day of prednisone (or equivalent dose) within 7 days prior to the first dose. 11. Expected survival time>3 months; 12. Adequate organ function, subjects must meet the following laboratory indicators: 1) In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) is >= 1.5x10^9/L; 2) Platelets >= 100 × 10^9/L without blood transfusion in the past 14 days; 3) Hemoglobin>9g/dL in the past 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin = 60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included); 13. For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year o
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria are not eligible for this study: 1. Pathological diagnosis of small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC; 2. Received the following treatments: 1) Received systemic anti-tumor therapy within 3 weeks prior to treatment, such as chemotherapy, targeted therapy, immunotherapy (including herbal therapy with anti-tumor indications), etc; 2) Received any investigational drug treatment within 4 weeks prior to treatment; 3) Received high doses of immunosuppressive drugs (systemic corticosteroids exceeding 10mg/day of prednisone or its equivalent) within 4 weeks prior to treatment; 4) Received attenuated live vaccine within 4 weeks prior to treatment (or planned to receive attenuated live vaccine during the study period); 5) Has undergone major surgery (such as open cavity, thoracotomy, or Kaifu surgery) within 4 weeks before treatment, or has unhealed surgical wounds, ulcers, or fractures. 3. There is clinically uncontrollable pleural/peritoneal effusion (subjects who do not require drainage or have no significant increase in effusion after stopping drainage for 3 days can be enrolled); 4. Subjects who have received chest radiation therapy greater than 30 Gy within the 6 months prior to treatment or palliative radiation therapy with a dose of 30 Gy or less within the 7 days prior to treatment (palliative radiation therapy for bone lesions or intracranial lesions is allowed); 5. Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments; 6. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the active ingredients or excipients of the drugs in this study, such as liracitinib and bevacizumab; 8. Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., <= grade 1 or baseline, excluding fatigue or hair loss); 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 10. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: 1) Before the first administration, the HBV viral load was less than 1000 copies/ml (200 IU/ml), and subjects should receive anti HBV treatment throughout the entire study drug treatment period to avoid viral reactivation 2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary 11. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 12. Administer a live vaccine within 30 days prior to the first dose (Day 1 of the first cycle); Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; However, intranasal administration of att
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactDu Fenghua
Anhui Chest Hospital
Outcome results
None listed