Non-squamous non-small cell lung cancer
Conditions
Interventions
experimental group:JS004+Toripalimab+Docetaxel
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily signed written informed consent; 2) Aged 18-75 years at the time of signing informed consent, both men and women; 3) Expected survival >= 3 months; 4) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5) Pathologically confirmed advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) without EGFR sensitive mutation or ALK fusion; 6) Previous PD-1/PD-L1 inhibitors combined with platinum-based doublet chemotherapy or sequential treatment as first-line/second-line treatment for advanced metastatic or recurrent NSCLC and disease progression during or after treatment; 7) Previous radical surgery or radiotherapy-based, platinum-based chemotherapy and PD-1/PD-L1 combined therapy (including neoadjuvant, adjuvant/consolidation therapy),Progression during adjuvant/consolidation therapy with PD-1/PD-L1 inhibitors; 8) At least one measurable lesion as a target lesion (RECISTv1.1 criteria); 9) Patients with good organ function as indicated by laboratory test results at screening: a) hematology (no blood transfusion and no blood component or granulocyte colony-factor therapy within 14 days): neutrophil count (NEU) >= 1.5 × 10^9/L (1,500/mm3); platelet (PLT) count >= 100 × 10^9/L (100,000/mm3); hemoglobin >= 90 g/L; b) Liver: serum total bilirubin (TBil) = 30 mL/min d) Coagulation function: international normalized ratio (INR) <= 1.5, and prothrombin time (PT) or activated partial thromboplastin time (APTT) <= 1.5 × ULN; 10) Male patients with reproductive capacity or female patients with the possibility of pregnancy, use effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive devices or barrier contraceptives combined with spermicides) during the trial, and continue contraception for 6 months after the end of treatment; 11) Good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1) EGFR sensitive mutation or ALK fusion; 2) previously treated with toripalimab or docetaxel; 3) received systemic anti-tumor therapy within 3 weeks before the first study medication, including: chemotherapy, targeted therapy, anti-vascular drug therapy, biological therapy, immunotherapy, radiotherapy or other investigational drug therapy; except: a) oral drug withdrawal 5 half-lives can be enrolled; b) palliative radiotherapy (such as bone metastasis radiotherapy to control pain, etc.) and is not expected to affect bone marrow hematopoietic function, 2 weeks after the end of the group; c) anti-tumor indications of traditional Chinese medicine treatment 1 week off can be enrolled; 4) adverse reactions caused by previous treatment did not recover to CTCAE (version 5.0) grade 1 and below (except for long-term, can not recover and does not increase the safety risk of 10 mg/day or equivalent) or other immunosuppressive drugs within 14 days before the first study; 13) Patients with a history of immunodeficiency, including other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;Or received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 14) received live vaccination within 4 weeks before the first study medication; 15) underwent major surgical procedures (as defined by the investigator, such as open biopsy, severe trauma, etc.) within 4 weeks before the first study medication.Planned major surgical procedures within 30 days of first dose (at the discretion of the investigator) or who have not fully recovered from previous surgery.Local procedures (eg, placement of systemic ports, core needle biopsy, replacement of intravenous drip tubes, etc) were permitted provided that the procedure was completed at least 24 hours before the first dose of study; 16) had severe cardiovascular or cerebrovascular disease: a) poorly controlled hypertension or pulmonary hypertension; b) unstable angina pectoris or myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months before study medication; c) chronic heart failure and cardiac function >= 2 (New York Heart Association NYHA classification); d) left
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease control rate;duration of response;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactZhang yan; Luo Feng
West China Hospital of Sichuan University
Outcome results
None listed