lung cancer
Conditions
Interventions
Experimental group: SHR-2002 injection combined with Adebrelimab injection 1200mg Q3W and Docetaxel injection 75mg/m2 Q3W
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, both genders; 2. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC. Participants with nonsquamous tumors were required to have available genetic testing to confirm without EGFR, ALK, or ROS1 driver mutations; (Advanced stage is defined as stage IIIb-IV according to the 8th edition of the IASLC TNM staging criteria, and no longer suitable for radical surgery or radiotherapy.) 3. Disease progression after prior immunization (PD-1/L1 antibody), platinum-based chemotherapy, and the response or stable time after immunotherapy was =3 months; 4. At least one measurable lesion that met RECIST v1.1 criteria; 5. ECOG Performance Status of 0-2; 6. Must have life-expectancy of = 3 months; 7. Adequate function of major organs meets the following requirements; (1)Blood routine •ANC=1.5×109/L; •PLT=75×109/L; •Hb=90 g/L; (2)Renal function •Urea nitrogen = 1.5 × ULN; Cr=1.5 × ULN or creatinine clearance =50 mL / min (Cockcroft-Gault formula); (3) Cardiac ultrasound •LVEF=50%; •12-lead ECG: females QTcF interval <470msec and males <450ms; (4) Liver function •TBIL=1.5 × ULN; •ALT and AST=3 × ULN (liver metastasis=5.0 × ULN); •ALP=2.5× ULN (Bone and/or liver metastasis=5.0 × ULN); •ALB=30g/L; (5) Coagulation •INR or PT=1.5×ULN,APTT=1.5×ULN; 8. Childbearing age female patients who were not surgically sterilized had to undergo a serum pregnancy test with a negative result within 7 days before starting study treatment. Female patients of childbearing age or male patients whose partner was a female of childbearing age had to consent to use a highly effective method of contraception for the duration of the study and for 6 months after the last dose of study drug;
Exclusion criteria
Exclusion criteria: 1. More than 10% of the tumor tissue was histologically or cytologically confirmed as small-cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous-cell carcinoma ; 2. Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. 3. Imaging examination showed that the tumor invaded the large blood vessels or had unclear boundaries with blood vessels. Or the investigator's judgment that the subject's tumor has a high probability of invading important blood vessels during treatment and causing fatal bleeding ; 4. Patients who had clinically significant bleeding symptoms or bleeding tendency within 3 months before the first study medication, such as hemoptysis, hematemesis, hematochezia, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc. 5. Patients with uncontrollable pleural effusion, pericardial effusion or peritoneal effusion requiring puncture and drainage as judged by the investigator; Or received ascites or pleural effusion drainage within 14 days before the first medication ; 6. Patients with previous or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, papillary thyroid carcinoma, and other malignant tumors that had been adequately treated and cured for more than 5 years without evidence of recurrence and metastasis before the first dose of medication ; 7. Previous anti-PVRIG or TIGIT antibody anti-tumor therapy ; 8. A history of immunodeficiency, including testing positive for HIV, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation ; 9. Patients have poorly controlled or severe cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure (NYHA class II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or myocardial infarction within 6 months before the first dose of medication ; 10. Arterial/venous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months before the first dose of the drug ; 11. Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, persistent pneumonia, drug-induced or radiotherapy-induced pneumonia, congenital pneumonia, or any evidence of active pneumonia on chest CT scan that may interfere with the diagnosis of immune-related pulmonary toxicity; At present, pulmonary function tests have confirmed that pulmonary function is severely impaired; 12. Patients with active chronic enteritis (including ulcerative colitis and Crohn's disease) within 6 months before the first drug administration or with intestinal obstruction or gastrointestinal perforation within 3 months before the first drug administration. Refractory malignancy, vomiting, chronic gastrointestinal diseases, etc. 13. Active hepatitis B (HBV DNA = 500 IU/mL or =2500 copy/mL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the lower limit of assay detection); 14. Severe infection, including but not limited to bacteremia requiring hospitalization and severe pneumonia, occurs within 4 weeks prior to the first medication; Active infection of grade CTCAE=2 requiring systemic antibiotic treatment within 2 weeks prior to the first dose; Or unexplained fev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Object response rate;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DoR;DCR; | — |
Countries
China
Contacts
Public ContactHe Zhiyong
Fujian Cancer Hospital
Outcome results
None listed