Non-Small Cell Lung Cancer
Conditions
Interventions
Treatment group:SHR-A1921+adebrelimab
Sponsors
shanghai pulmonary hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willing to join in this study, signed informed consent, good adherence, can cooperate with the follow-up; 2. Age 18-75 years old, both genders; 3. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC(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 combined with chemotherapy; 4. Participants with nonsquamous tumors were required to have available genetic testing to confirm without EGFR, ALK, or ROS1 driver mutations; 5. Disease progression after prior immunization (PD-1/L1 antibody)or combined with platinum-based chemotherapy; 6. At least one measurable lesion that met RECIST v1.1 criteria; 7. ECOG Performance Status of 0-1; 8. Must have life-expectancy of = 12 weeks; 9. Adequate function of marrow and major organs meets the following requirements: a) Blood routine (no blood transfusion or hematopoietic stimulating factor therapy within 14 days before examination):ANC=1.5×109/L;PLT=75×109/L;Hb=90 g/L; b) Liver function (no hepatoprotective drugs within 7 days before the examination):ALT and AST=3 × ULN (liver metastasis=5.0 × ULN); TBIL=1.5 × ULN(Gilbert's syndrome subjects:TBIL=3mg/dL); c) Renal function:Cr=1.5 × ULN or creatinine clearance =60 mL / min (Cockcroft-Gault formula); d) Coagulation: INR or PT=1.5×ULN,APTT=1.5×ULN; e) Cardiac ultrasound: LVEF=50%. 10. 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; and have no plans to have children or to donate sperm or eggs, 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.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of any drug containing a topoisomerase I inhibitor drug, including antibody-drug conjugates; 2. Previous receipt of TROP2-targeted therapy; 3. Grade 3 or above immune-related adverse events occurred during previous immunotherapy, such as immune-related interstitial lung disease, immune-related myocarditis, immune hepatitis, etc.; 4. More than 10% of the tumor tissue was histologically or cytologically confirmed as small-cell lung cancer, neuroendocrine carcinoma, carcinosarcoma; 5. Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. Patients who had received previous treatment for brain metastases (radiotherapy or surgery) were eligible for enrollment if they had been stable for at least 4 weeks as confirmed by imaging and had been free of systemic hormone therapy (at a dose of >10 mg per day of prednisone or the equivalent) for more than 2 weeks and were asymptomatic; 6. Spinal cord compression that could not be cured by surgery and/or radiotherapy; 7. Patients with uncontrolled cancer-related pain as judged by the investigator; 8. Patients with symptomatic pleural effusion, pericardial effusion, or ascites requiring drainage or those who had undergone therapeutic drainage of serous effusion within 2 weeks before the administration of the study drug; 9. Patients who received anti-tumor therapy such as chemotherapy within 4 weeks before the first dose of medication, or received lung field radiotherapy >30Gy within 6 months before the first dose of medication; 10) Surgical surgery or significant trauma to major organs within 4 weeks prior to the first dose of study drug; 11) Other malignant tumors complicated = 5 years prior to the first dose; 12) Have interstitial lung disease such as a history of idiopathic pulmonary fibrosis or suspicious imaging examination at screening Patients with qualitative pneumonia or interstitial pneumonia that cannot be ruled out; 13) Those who have active tuberculosis infection within 1 year prior to enrollment as found by medical history or CT examination; 14) Severe infection within 4 weeks prior to the first dose; 15) Have severe cardiovascular and cerebrovascular diseases; 16) Those who have had significant clinically significant bleeding symptoms within 3 months before the first study drug; 17) Artial/venous thrombotic events occurring within 6 months prior to the first study administration; 18) Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy; 19) Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.; 20) Active, known or suspected autoimmune disease (including positive HIV test) or history of organ transplantation subjects; 21) Presence of active hepatitis B or hepatitis C; 22) Vaccination with a live vaccine or live attenuated vaccine within 4 weeks prior to the first dose of study drug; 23) Adverse reactions from prior anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation = grade 1; 24) History of severe allergic reactions to other monoclonal antibodies, or to SHR-A1921 and adebelimab Those who have an allergic reaction to any of the ingredients; 25) In the judgment of the investigator, there are other reasons that may affect the results of the study or cause the study to be terminated in the middle of the study Elements, such as alcoh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactChunxia Su
shanghai pulmonary hospital
Outcome results
None listed