lung cancer
Conditions
Interventions
Experimental group1:PM8001 plus chemotherapy
Experimental group2:PM8001 plus targeted drugs
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand this research and sign the informed consent voluntarily; be willing to follow and have the ability to complete all experimental procedures; 2. Male or female, aged 18 to 75 years (inclusive); 3. Stage Ia: subjects with malignant tumor confirmed by histology or cytology; Stage Ib: subjects with lung cancer confirmed by histology or cytology 4. Subjects must provide tumor tissue samples for PD-L1 analysis; 5. All toxic reactions caused by previous anti-tumor therapy are relieved to grade 0-1; 6. Having adequate organ function, defined as follows: (1) Blood system: Neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count (PLT) >= 100 x 10^9/L; Hemoglobin (Hb) >= 90 g/L; (2) Liver function: total bilirubin (TBIL) level = 50ml/min; qualitative urine protein = 2+, a 24-hour urine protein quantitative test is required, such as 24-hour urine protein The protein quantification is less than 1g, it is acceptable; (4) Coagulation function: International normalized ratio (INR), prothrombin time (PT) or activated partial thromboplastin time (APTT) are all = 12 weeks; 9. According to RECIST 1.1 criteria, the subject has at least 1 measurable lesion; 10. Female subjects of childbearing potential must have a negative blood pregnancy result within 7 days before the first start of study treatment, and be willing to abstain from sex or take medically-approved medication from the time of signing the informed consent to 6 months after the end of the last medication. Approved high-efficiency contraceptives (eg, IUDs, condoms); 11. Male subjects are willing to keep abstinence or take medically approved high-efficiency contraceptive measures from the time of signing the informed consent to 6 months after the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease, severe drug allergy or known allergy to any drug or drug component of the study drug; 2. Previously received targeted therapy on TGF-ß; 3. Major surgery or clinically significant unhealed wounds, ulcers or fractures within 28 days before the start of the study treatment; corticosteroids or other immunosuppressive drugs within 14 days before the start of the study treatment; 28 days before the start of the study treatment Received live attenuated vaccine within days; systemic antibiotics used for >= 7 days within 2 weeks before the start of study treatment; 4. The presence of meningeal metastasis, or uncontrolled central nervous system (CNS) metastasis; 5. There is any active autoimmune disease or a history of autoimmune disease and relapse is expected; 6. Suffered from other active malignant tumors within 5 years before the start of study treatment; 7. Within 6 months before the start of study treatment, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident/stroke, New York Heart Association (NYHA) classification of grade II or above (including grade II) cardiac insufficiency; 8. Uncontrollable pleural and pericardial effusion within 4 weeks before starting treatment; 9. Unexplained fever > 38.5 degree C before starting study treatment; 10. Before starting study treatment, there is: congenital long QT syndrome; use of cardiac pacemaker; left ventricular ejection fraction (LVEF) 480 msec; clinically significant arrhythmia requiring clinical Intervention; cardiac troponin I or T > 2.0 ULN; poorly controlled diabetes (fasting blood glucose >= 13.3 mM); poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >= 100 mmHg); 11. When receiving immunotherapy in the past, there have been immunotherapy-related adverse events (irAE) of grade >= 3; 12. There is uncontrollable tumor-related pain; 13. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Known history of alcohol abuse, psychotropic substance abuse or drug abuse; 15. Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.; 16. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 17. Syphilis antibody positive; 18. Active pulmonary tuberculosis; 19. Hepatitis B virus carriers, hepatitis B patients who have been stabilized by drug treatment or those who have been cured of hepatitis C patients; 20. According to the judgment of the investigator, the subject's underlying condition may increase the risk of receiving the study drug; 21. Expected to receive any other form of antitumor drug treatment during the study period; 22. Women who are pregnant or breastfeeding; 23. Other researchers think that it is not suitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT occurred within 21 days after first administration;Progression-free survival; | — |
Countries
China
Contacts
Public ContactLu Shun
Shanghai Chest Hospital
Outcome results
None listed