CTIS2024-513087-26-00进行中（未招募）1 期
A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3) - SMT112-3003
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Voluntarily sign a written informed consent form (ICF), Adequate Organ Function: a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) = 1.5 × 109/L ii. Platelet count = 100 × 109/L iii. Hemoglobin = 9.0 g/dL b. Kidneys: i. Creatinine clearance (CrCl) = 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value =50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR) *CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org). ii. Urine protein < 2+ or 24 hour urine protein quantification < 1.0 g c. Liver: i. Serum total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN); For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL =3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; For patients with liver metastases, AST and ALT = 5 × ULN d. Coagulation: prothrombin time (PT) or international normalized ratio (INR) = 1.5 x ULN, and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) = 1.5 × ULN (unless abnormalities are unrelated to coagulopathy,or prophylactic coagulation), Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing., Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of ivonescimab/pembrolizumab or until 6 months after last dose of chemotherapy (whichever is longer)., Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 120 after the last dose of ivonescimab/pembrolizumab or until 6 months after last dose of chemotherapy (whichever is longer)., Age = 18 years old at the time of enrollment, Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, Expected life expectancy = 3 months, Metastatic (Stage IV) NSCLC, according to American Joint Committee on Cancer (AJCC) 8th edition, Histologically or cytologically confirmed squamous NSCLC. Patients with mixed histology (eg, adenosquamous) are allowed if there is squamous component., Patients must have Tumor Proportion Score (TPS) with PD-L1 expression percent (from available reports or archival tumor tissue based on a 22C3 IHC clinical assay approved/cleared by health authorities ) or provide tissue for measurement of PD-L1 expression., At least one measurable noncerebral lesion according to RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions since radiotherapy., No prior systemic treatment for metastatic NSCLC. Patients receiving adjuvant or neoadjuvant chemotherapy or curative-intent chemoradiotherapy with or without PD- 1/L1 inhibitors are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
排除标准
- •Histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology., Patients with > 30 Gy of chest radiation therapy within 6 months prior to randomization; non-thoracic radiation therapy > 30 Gy within 4 weeks prior to randomization, or palliative radiation therapy of = 30 Gy within 2 weeks prior to randomization, Has pre-existing peripheral neuropathy that is = Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 5, Live vaccine or live attenuated vaccine within 4 weeks prior to planned randomization, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted., Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C), Major surgical procedures or serious trauma within 4 weeks prior to randomization, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization., History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to: a. Gastrointestinal bleeding b. Hemoptysis (defined as coughing up = 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed. c. Nasal bleeding /epistaxis (bloody nasal discharge is allowed) d. Need for therapeutic anticoagulant therapy (eg, aspirin = 325 mg/day, anti- platelet agents such as clopidogrel, ticlopidine, and dipyridamole, vitamin K antagonists at therapeutic doses, or similar therapeutic anticoagulation) within 14 days prior to randomization Note: Prophylactic anticoagulation for DVT/PE or to maintain venous patency is allowed., Current hypertension with systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg after oral antihypertensive therapy, Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic. Note: Patients managed with indwelling catheters (eg, PleurX) are allowed., History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease, Active or prior history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea), Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1, or genes for which first-line approved therapies are available, Known history of human immunodeficiency virus (HIV), Current use of systemic corticosteroids (=10 mg daily prednisone or equivalent), Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by PCR on appropriate anti-viral therapy for one month prior to randomization. All active hepatitis C patients (hepatitis C virus [HCV] antibody positive with HCV RNA levels above the lower limit of detection) are excluded., Known allergy to any component of any study drug; known history of severe hypers
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