non-squamous and non-small cell lung cancer
Conditions
Interventions
1:M2ES:15 mg/m2
2:M2ES:30 mg/m2
3:M2ES:45 mg/m2
4:M2ES:60 mg/m2
5:M2ES:Target dose
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged>=18 years old male and female; 2. Histologically or cytologically confirmed patients with stage III/IV non-squamous non-small cell lung cancer who have received initial treatment or have not previously received chemotherapy, including but not limited to: (1) Initial patients with negative driving genes (such as EGFR, ALK, ROS1, etc.); (2) Patients with positive driving genes and progressing after targeted drug therapy; (3) Patients with recurrence after surgery who did not use chemotherapy or targeted drugs and whose interval with pre-adjuvant chemotherapy was more than 6 months; 3. No antineoplastic angiogenesis drugs have been used in the past(including but not limited to bevacizumab, antibiotics, apatinib, etc.); 4. According to RECIST 1.1 standard, there is at least one measurable lesion (conventional CT scan (>=20 mm), spiral CT scan (>=10 mm), measurable lesion without radiotherapy); 5. Expected survival time >3 months; 6. The physical condition of the Eastern Cancer Cooperative Group (ECOG) =1.5*10^9/L; (2) Hemoglobin (Hb)>=90g/L (maintained by blood transfusion); (3) Platelet count (PLT)>=100*10^9/L; (4) Creatinine clearance rate (Cr)>=60 mL/min; (5) Total bilirubin (TBIL)<=1.5*ULN; (6) Serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5*ULN, or when the liver metastasis of tumors resulted in their elevation, ALT and AST <=5*ULN; (7) Alkaline phosphatase (ALP)<=2.5*ULN, or when the researcher judges that the elevation of ALP is due to liver metastasis of tumors,<=5*ULN; (8) The International Standardized Ratio (INR) is within the normal range; (9) Partial prothrombin kinase time (APTT)<=1.2*ULN. 8. Agree to take effective contraceptive measures during the study period; 9. According to the judgement of the researcher, the subjects were considered to be able to comply with the scheme.
Exclusion criteria
Exclusion criteria: (1) Within four weeks before the first use of the research product in this study, participants are taking part in or had participated in clinical trials of any other research products or medical devices; (2) The toxicity related to anticancer therapy did not recover in the past, and the severity exceeded grade 1(NCI-CTCAE 5.0, except alopecia and pigmentation); (3) Radical radiotherapy or acute or subacute toxicity which had not been recovered before radiotherapy were performed in the past 6 months; local palliative radiotherapy was less than 2 weeks away from this study (except palliative radiotherapy for bone metastases); (4) Female subjects during pregnancy or lactation are unwilling or unable to use effective contraceptive measures within the prescribed time (from 2 weeks before receiving the research drug to 30 days after receiving the last research product); (5) Antiarrhythmic therapy is required. Previous history of severe symptomatic coronary artery disease (including unstable angina and myocardial infarction) or history of myocardial ischemia or congestive heart failure exceeds NYHA II; (6) Screening for cerebrovascular accidents within the first six months, including but not limited to transient ischemic attack (TIA), or untreated deep vein thrombosis (DVT); (7) Patients with previous hypertension crisis or hypertensive encephalopathy, uncontrolled hypertension (uncontrolled after no more than two antihypertensive drugs), systolic blood pressure (SBP) > 140 mm Hg or diastolic blood pressure (DBP) > 90 mm Hg (the above results are the average of three measurements); (8) For biological agents, PEG recombinant human endostatin (including excipients of this product), drug allergies of the same kind, or severe allergic constitutions; (9) Subject presence: Substance abuse, active infections (including but not limited to active HIV, hepatitis B and hepatitis C infections), other acute or chronic physical or mental illnesses or laboratory abnormalities that researchers believe may increase the risk associated with participating in the study; (10) Symptomatic brain or meningeal metastasis (unless the patient receives brain metastasis therapy for more than 6 months and the imaging results within 4 weeks prior to the study show that the lesion is stable). (11) Significant amounts of ascites or symptomatic pleural effusion of clinical significance (except for patients who have achieved clinical stability after treatment of these conditions); (12) Significant clinical abnormalities that may increase the risk of gastrointestinal bleeding, such as active peptic ulcer, known intrathoracic and abdominal metastases at risk of bleeding, inflammatory bowel disease (Crohn's disease, ulcerative colitis), etc.; (13) The presence of bronchial lesions or infiltration of pulmonary vessels (e.g. pulmonary artery) lesions; (14) Significant hemoptysis (coughing up at least 1 mL of blood) occurred within 8 weeks before the first administration; (15) Severe active infections, including, but not limited to, abdominal infections and urinary tract infections, which can significantly affect clinical research; (16) Patients with hereditary bleeding tendency or coagulation disorder, which may increase the risk of bleeding, or who are receiving anticoagulant, antiplatelet and antithrombotic drugs such as heparin and acetone-biacetoxycoumarin. (17) Those with a history of alcohol allergy; (18) Suffering from uncontrollable mental illness; (19) I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| M2ES plasma concentration;M2ES antibody concentration;Target lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor microenvironment;biomarkers;Non-target lesions; | — |
Countries
China
Contacts
Public ContactLi Zhang; Su Li
Sun Yat-sen University Cancer Center
Outcome results
None listed