Squamous non-small cell lung cancer
Conditions
Interventions
The experimental group:Camrelizumab, 200mg, Q3W, IV+ fluzoparib, 150mg, BID.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 (including 18 and 75); 2. Understand the research steps and content, and voluntarily sign a written informed consent; 3. Stage IV squamous non-small cell lung cancer confirmed by histopathology or cytology. ; 4. There is at least one measurable lesion, according to RECIST 1.1 criteria; 5. First-line treatment with PD-1 inhibitor + platinum + taxane for 4-6 cycles, no progression by imaging assessment and no more than 28 days of drug withdrawal; 6. Physical condition score (ECOG PS score): 0-1 points; 7. Expected survival period >= 3 months; 8. The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count> 1.5x10^9/L; platelets Count >= 100x10^9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 9. Thyroid function indicators: Thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range or mild and no clinically significant abnormalities; 10. Weight over 40 kg (including 40 kg), or BMI > 18.5; 11. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first dose, and the result is negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to use a highly effective method of contraception during the study and within 180 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of other malignancies, unless it is carcinoma in situ that has achieved complete remission at least 5 years before screening and does not require or is expected to require no other treatment during the study period; 2. Subjects with any known or suspected autoimmune disease, except: patients with a history of hypothyroidism, if hormone therapy is not required, or are receiving physiological doses of hormone replacement therapy; patients with stable type I diabetes mellitus with controlled blood sugar; examinee; 3. Subjects with known or suspected interstitial pneumonia; other moderate-to-severe pulmonary diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function. Including, for example, idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, etc.; 4. Subjects with severe cardiovascular and cerebrovascular diseases, such as those who meet NYHA criteria (grade III or higher), or myocardial infarction or cerebrovascular accident (brain deficiency) occurred within 3 months before the first dose. blood, symptomatic cerebral infarction, etc.), or with coronary artery disease and unstable arrhythmia or unstable angina pectoris occurred within 1 month before the first dose, or congestive heart failure other than the above criteria, or Left ventricular ejection fraction =2 weeks; 10. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before screening, such as gastrointestinal bleeding, gastric ulcer bleeding or vasculitis; 11. There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 12. Local palliative radiotherapy is allowed for symptomatic metastases, but should be completed before screening, and the toxicity has recovered, and the minimum recovery time is not required; asymptomatic metastases, such as further growth, may lead to dysfunction or intractable pain (such as Epidural bone metastases that do not show spinal cord compression temporarily), if allowed, should receive local treatment before screening; 13. Uncontrollable moderate to large pleural effusion, ascites or pericardial effusion requiring repeated drainage; 14. Those who are known to be positive for EGFR/ALK gene mutation, and those whose EGFR/ALK gene mutation status is unknown are not required to be tested; 15. History of sever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactShen Bo
Jiangsu Cancer Hospital
Outcome results
None listed