Non-small cell lung cancer
Conditions
Interventions
Group 1:Anlotinib combined with pemetrexed and carboplatin
Group 2:Pemetrexed and carboplatin
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up; 2. Male or female patients between the ages of 18-75 years; 3. Histologically or cytologically confirmed locally advanced (stage IIIb), metastatic (stage IV) or recurrent non-squamous NSCLC patients; 4. For recurrent disease, adjuvant therapy (adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy) will relapse after half a year; 5. At least one measurable lesion as a target lesion (according to RECIST 1.1); 6. The expected survival period is =3 months; 7. ECOG PS 0-1 points; 8. The main organ function meets the following criteria: (1)Blood routine test: Hemoglobin > 80g/L; Absolute neutrophil count (ANC) >1.5×10^9/L; Platelets >80×10^9/L; (2)biochemical tests: Serum total bilirubin <1.5 times the normal upper limit; ALT, AST < 2.5 times the normal upper limit,<5 times the normal upper limit (with liver metastases); Serum creatinine < 1.25 times the normal upper limit; 9. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative and willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Genetic testing suggests EGFR, ALK or ROS1 positive; 2. Imaging (CT or MRI) shows that the tumor lesion is = 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel, or there is a significant pulmonary cavity or necrotizing tumor; 3. Previous disease and comorbidities (1) Symptomatic brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MR1 screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms 28 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography to no cerebral hemorrhage symptoms); (2) The patient is participating in other clinical studies or is less than 4 weeks from the end of the previous clinical study; (3) Other active malignancies that require simultaneous treatment; (4) Patients with a history of malignant tumors who have undergone a curative treatment and have no disease recurrence within 5 years from the start of treatment, except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer; (5) Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency or receiving thrombolysis or anticoagulant therapy (except low molecular weight heparin); (6) Renal insufficiency:urine routine test protein = ++, and confirmed 24-h urine protein >1.0 g; (7) Blood pressure control that is not ideal (systolic blood pressure =160 mmHg, diastolic blood pressure =100 mmHg); (8) Subjects who have undergone major surgery or have severe trauma have had less than 14 days of surgery or trauma removed prior to enrollment; (9) Severe acute or chronic infection requiring systemic treatment; (10) Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval = 450 ms, women = 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%; (11) Peripheral neuropathy with =CTCAE2 degrees currently present, except for trauma; (12) Respiratory syndrome (=CTCAE level 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment; (13) Long-term unhealed wound or fracture; (14) Diabetes with poor glycemic control or other impediments for high-dose glucocorticoid therapy; (15) Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; (16) Clinically significant hemoptysis (daily hemoptysis greater than 50ml) occurred within 3 months prior to enrollment,or significant clinically bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer,baseline fecal occult blood++ and above,or suffering from vasculitis, etc.; (17) Dynamic and venous thrombosis events that occurred more than 6 months after treatment before enrollment, such as cerebrovascular accidents (including transient ischemic attacks,cerebral hemorrhage, cerebral infarction),deep vein thrombosis,and pulmonary embolism; (18) Planned systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, or during 4 weeks prior to enrollm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective response rate;AEs; | — |
Countries
China
Contacts
Public ContactZeng Aiping
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed