Lung squamous cell carcinomas
Conditions
Interventions
1:sintilimab combined with paclitaxel/platinum-based short-course chemotherapy
Sponsors
Henan Tumor Hospital/ Affiliated Tumor Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-75 years; 2. The subject voluntarily agrees to participate and signs the informed consent; 3. Locally advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology. For subjects with mixed lung squamous cell carcinoma, if the squamous cell carcinoma content is >50%, the researcher will decide whether to be enrolled in the group according to the specific situation; 4. Never received systemic therapy for advanced or metastatic diseases. Subjects who had previously received neoadjuvant/adjuvant therapy or chemoradiotherapy for therapeutic purposes and confirmed recurrence of disease at least 6 months after completion of the last treatment were admitted to the group; 5. Subjects must be able to provide fresh or archived tumor tissue (formalin fixed, paraffin-embedded [FFPE] tissue mass or at least 10 unstained FFPE slides) and pathology reports. Note: lung squamous cell carcinoma subjects with unknown EGFR and/or ALK mutation status will be required to provide additional tumor tissue for testing at the study center (or other designated centers).If the subject can provide less than 10 unstained slides, it is up to the researcher to decide whether to enroll or not according to the specific situation; 6. There was at least one measurable lesion that met the RECIST 1.1 criteria, i.e., non-lymph node lesion length diameter > 10 mm or lymph node lesion short diameter > 15 mm as per CT cross-sectional images; 7. ECOG score 0-1; 8. The expected survival time is not less than 12 weeks; 9. The functions of vital organs and bone marrow meet the following requirements: 1) Routine blood: the absolute neutrophil count (ANC) =1.5 x 10^9/L , the platelet (PLT)= 100 x 10^9/L,hemoglobin (HGB)= 9 g/dL ;(note: this standard must be met without transfusion within 4 weeks prior to sample acquisition); 2) Liver function, serum total bilirubin (TBIL) acuities were 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)=2.5 x ULN, if liver function is abnormal because of hepatocellular carcinoma (HCC) or cancer that has spread to the liver, AST and ALT= 5 times ULN, serum albumin (propagated) =2.8 g/dL; 3) Renal function, serum creatinine (Cr) =1.5 x ULN, or creatinine clearance = 40 ml/min; 10. For women of child-bearing age, pregnancy test reports should be provided within 3 days before the start of treatment, and the results should be negative; 11. Fertile women will be required to use high-potency contraception during the study period and at least 120 days after the last administration of cindilizumab and at least 180 days after the last chemotherapy.It is recommended to start using contraceptives at least 3 months before the first dose of the study treatment; 12. Men who were not sterilized were required to use effective contraception for at least 180 days during the study period, and after the last administration of sintilimab and the last chemotherapy. It is recommended to start using contraceptives at least 3 months before the first dose of the study treatment.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma patients with positive driver genes (EGFR/ROS1/ALK, etc.); 2. Symptomatic central nervous metastasis. Patients with asymptomatic brain metastases or stable symptoms after treatment can participate in this study as long as they meet all the following criteria: measurable lesions outside the central nervous system; No midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastasis; Does not require hormone therapy and remains clinically stable for at least 2 weeks; 3. Previously received anti-tumor therapy for other malignant tumors, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine therapy (except the previous radical treatment for malignant tumors with no recurrence and metastasis for more than 5 years); 4. Patients with uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage (patients who do not need drainage effusion or have no obvious increase in effusion after 3 days of stopping drainage can be enrolled); 5. Immunosuppressive drugs were used within 4 weeks prior to the first dose of study therapy, excluding nasal spray, inhalation or other route of local glucocorticoids or systemic glucocorticoids at a physiological dose (i.e., no more than 10mg/ day prednisone or equivalent dose of other glucocorticoids); 6. Patients with known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (vitiligo or asthma in childhood have been completely relieved, and adult patients without any intervention can be enrolled; Type 1 diabetes patients with good insulin control can also be enrolled); 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Allergic to any component of monoclonal antibody; 9. Now suffering from interstitial lung disease; 10. Suffering from other serious uncontrolled diseases, including but not limited to: 1) severe infection in the active stage or under poor clinical control; 2) HIV infection (HIV antibody positive); 3) patients with acute or chronic active hepatitis b (HBsAg positive and HBVDNA>1*103/ml) or acute or chronic active hepatitis c (HCV antibody positive and HCV RNA>15IU/ml); 4) active tuberculosis, etc.; 5) grade iii-iv congestive heart failure (New York heart association classification), poorly controlled and clinically significant arrhythmias; 6) uncontrollable arterial hypertension (systolic blood pressure 160mmHg or diastolic blood pressure 100mmHg); 7) any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the inclusion in the treatment; 8) diseases requiring anticoagulant treatment with farvarin (coumarin); 9) uncontrolled hypercalcemia (> 1.5 mmol/L of calcium ions or > 12mg/dL of calcium or > ULN of corrected serum calcium), or symptomatic hypercalcemia requiring further bisphosphate-therapy; 10) accompanied by other malignant tumors (except those that have been radically cured, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.); 11) other acute or chronic diseases, mental diseases or abnormal laboratory test values that may lead to the following results: increase the risk associated with study participation or study drug administratio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;objective response rate;duration of response;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactHuijuan Wang
He'nan Tumor Hospital/ Affiliated Tumor Hospital of Zhengzhou University
Outcome results
None listed