Non-Small Cell Lung Cancer
Conditions
Interventions
Arm A:Sintilimab (200mg, Q3W) combined with ipilimumab N01 (1 mg/kg, Q6W) and chemotherapy (intravenously Q3W for 2 cycles) . In the maintenance therapy, Sintilimab (200mg, Q3W) combined with ipilimum
Arm B:Sintilimab (200mg, Q3W) combined with ipilimumab N01 (1 mg/kg, Q6W) and chemotherapy (intravenously Q3W for 4 cycles) . In the maintenance therapy, Sintilimab (200mg, Q3W) combined with ipilimum
Sponsors
PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Fully understand this research and voluntarily sign the informed consent form (ICF); 2.>=18 years old,no gender limit; 3. Diagnosed as NSCLC by histopathology or cytology; 4. Localized late stage status that is inoperable and cannot accept curative concurrent chemoradiotherapy, metastatic status, and clinical staging including stages IIIB, IIIC, and IV (AJCC 9th version); 5.No EGFR/ALK/RET/ROS1/HER2/MET mutation or fusion was detected; 6.Patients without a history of other malignant tumors; 7.Tumor tissue IHC PD-L1 TPS = 90g/L, absolute neutrophil count(ANC) >= 1.5 x 10^9/L, platelet(PLT) >= 70 x 10^9 /L; (2) Liver function: Serum total bilirubin (TBIL) = 28 g/L; Alkaline phosphatase (ALP) = 50 mL/mi (using the standard Cockcroft Gault formula): (4) Coagulation function: International Normalized Ratio (INR) <= 1.5/PT <= 1.5 × ULN, aPTT <= 1.5 × ULN; If the subject is receiving anticoagulant therapy, as long as the PT and INR are within the range specified by the anticoagulant drug, it is sufficient; 13. For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; 14. If there is a risk of conception, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days (or 180 days) after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed tumor with small cell lung cancer component; 2. Symptomatic brain metastases; however, patients with asymptomatic brain metastases (=28 days after treatment, confirmed by repeat imaging prior to enrollment, are eligible; 3. Prior treatment with immune checkpoint inhibitors; 4. Currently participating in an interventional clinical trial, or received any investigational drug or device within 4 weeks prior to first dose; 5. Systemic administration of traditional Chinese medicine (TCM) with anti-lung cancer indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin) within 2 weeks prior to first dose, excluding local use for pleural effusion control; 6. Active autoimmune disease or concomitant use of immunosuppressive drugs; 7. Systemic corticosteroid therapy (excluding nasal, inhaled, or other local routes) or any other form of immunosuppressive therapy within 7 days prior to first dose; 8. History of steroid-treated pneumonia or interstitial lung disease within 1 year prior to first dose; 9. Palliative radiotherapy within 7 days prior to first dose. For patients receiving palliative radiotherapy >7 days prior, eligibility requires: absence of any radiation-related toxicity, no requirement for corticosteroids, exclusion of radiation pneumonitis; and no prior lung radiotherapy >30 Gy within the last 6 months; 10. Receipt of live attenuated vaccine within 4 weeks prior to first dose, or planned administration during the study; Note: Inactivated seasonal influenza vaccine is permitted within 4 weeks prior; live attenuated influenza vaccine is prohibited; 11. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapies (e.g., levothyroxine, insulin, physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; 12. Inadequate recovery from prior interventions (i.e., =3 days after drainage cessation are eligible; 14. Any unstable systemic disease, including but not limited to: active infection, congestive heart failure (NYHA class >=II), severe arrhythmias requiring medication, hepatic, renal, or metabolic disorders; Type I or II respiratory failure; tumor compression of vital organs (e.g., esophagus), superior vena cava syndrome, or invasion of mediastinal vessels, pericardium, or heart; history of gastrointestinal perforation or fistula within 6 months, bowel obstruction, extensive bowel resection, Crohn’s disease, ulcerative colitis, or chronic diarrhea; 15. Prior solid organ or hematopoietic stem cell transplantation (corneal transplantation excluded); 16. Known history of HIV infection (HIV-1/2 antibody positive) or active syphilis; 17. Active or currently requiring medical intervention for tuberculosis, including pulmonary tuberculosis; 18. Untreated active hepatitis B virus (HBV) infection; Note: Patients meeting the following criteria are eligible: (1) HBsAg(+) or HBcAb(+) with HBV DNA <1000 copies/mL (200 IU/mL) or below the lower limit of detection at screening; (2) HBsAg(+) patients must receive ongoing anti-HBV therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Disease control rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactYi Hu
PLA General Hospital
Outcome results
None listed