Non small cell lung cancer
Conditions
Interventions
Experimental group:Ralizumab in combination with androtinib, 2-cycle platinum dual drug
Sponsors
The Second Affiliated Hospital of Hainan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (including boundary value), no gender limit; 2. Locally advanced (stage IIIB, IIIC, or IV non-small cell lung cancer patients confirmed by histology to be incapable of radical surgery or radiotherapy (according to IASLC Lung Cancer Edition 8 TNM stage)); 3. Lung adenocarcinoma: EGFR/ALK/ROS1 gene test was negative (Note: patients with known EGFR mutation, ALK and ROS1 rearrangement were excluded; 4. Lung squamous cell carcinoma: If researchers consider it necessary to perform EGFR, ALK, ROS1 and other gene tests, relevant tests are feasible (For example, women with high risk factors such as non-smoking, EGFR and other mutations can be considered); No antitumor systemic therapy (Neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the cure of non-metastatic disease in the past, and the disease-free interval from the last chemotherapy and/or radiotherapy to the enrollment date must be >=6 months; Patients with bone metastases or spinal cord compression syndrome were treated with analgesic/palliative radiotherapy. Patients could be enrolled after radiotherapy, but the site of radiotherapy was not regarded as an evaluable lesion.) ; 5. Patients physical state score (ECOG) 0-1 (including boundary value); 6. Patient must have >=1 measurable lesion (according to RECIST1.1 criteria) : measurable lesion cannot be selected from previous radiotherapy site; 7. Expected survival >=3 months; 8. The patient's organ function must be adequate and the following laboratory test values must be achieved within 7 days prior to the initial study treatment: (1) Absolute neutral cell count (ANC) >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=90g/L. Remarks: Patients should not have received any blood transfusions, blood products, or stimulation of blood cell growth, such as granulocyte colony stimulating factor (G-CSF), within 7 days prior to blood sample collection; (2) International Normalized ratio (INR) or prothrombin time (PT) =50ml/min. Creatinine clearance was estimated based on cockcroft-Gault, X=[(140- age) x body weight (Kg) x female 0.85]/[0.818x serum creatinine (umol/L)]; 9. Patients understand the study content and sign the informed consent in person.
Exclusion criteria
Exclusion criteria: 1. Non-small cell lung cancer with other histopathological types, including but not limited to mixed squamous adenocarcinoma. 2. Central lung cancer with cavity and patients with active bleeding or at risk of bleeding. 3. Previous treatment with other antibodies/drugs targeting immune checkpoints, such as PD-1, PD-L1/CTLA-4, etc. 4. History of interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes mellitus, hypertension, pulmonary fibrosis, acute lung disease, etc. 5. Patients with any severe and/or uncontrolled illness or symptom, including: (1) Previous (within 5 years) or concurrent with other uncured malignancies, except for cured localized tumors; (2) Long-term antiplatelet therapy (aspirin >=300mg/ day, clopidogrel >=75mg/ day) is required; Note: Under the premise of INR =450ms for male and 470ms for female) (QTc interval was calculated by Fridericia formula); According to NYHA standard grade II or above cardiac insufficiency or color ultrasound: LVEF (left ventricular ejection fraction) 150mmHg, diastolic blood pressure >100mmHg after treatment with more than one antihypertensive drug), and patients with a history of hypertensive crisis or hypertensive encephalopathy; (5) Moderate to large amounts of pericardial effusion and pleural effusion that cannot be controlled after drainage or other symptomatic treatment (symptomatic treatment is allowed, but drugs with anti-tumor indications, such as chemotherapy drugs, anti-angiogenesis drugs and molecular targeting drugs, are not allowed); (6) Urine routine showed urine protein >=2+ and 24-hour urine protein quantity > 1.0g; (7) Active or uncontrolled severe infection, unexplained fever (body temperature >38.5?) prior to initial administration; (8) Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L). 6. Patients with active autoimmune disease or a history of autoimmune disease that may recur. Patients who were in stable condition and did not require systemic immunosuppressive therapy were allowed to be enrolled; Remarks: Patients with the following diseases are not excluded and can be further screened: (1) Controllable type I diabetes mellitus; (2) Hypothyroidism (if controlled with hormone replacement therapy alone); (3) Controlled celiac disease; (4) Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia); (5) Any other disease that will not recur in the absence of an external trigger. 7. Any condition requiring systemic corticosteroid therapy (dose higher than 10mg/ day of prednisone or equivalent) or other immunosuppressant treatment within <=14 days prior to enrollment; Remarks: Patients who are currently or previously on any of the following steroid regimens may be enrolled: (1) Adrenergic steroid replacement (prednisone <=10mg/ day or equivalent dose of similar drugs); (2) Local, ocular, intra-articular, intranasal and inhaled corticosteroids with minimal systemic absorption; (3) P
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Response Rate;Duration of Response;Disease Control Rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactLin Haifeng
The Second Affiliated Hospital of Hainan Medical College
Outcome results
None listed