NCT07362459招募中3 期
A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review
研究概览
简要总结
This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the written informed consent form prior to screening.
- •Age ≥ 18 years, both male and female.
- •ECOG Performance Status score of 0 to
- •An expected survival of ≥ 3 months.
- •Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) that is not amenable to curative surgery or radical concurrent/sequential chemoradiotherapy.
- •For subjects with non-squamous cell carcinoma, as well as non-smoking subjects with squamous cell carcinoma containing mixed adenocarcinoma components, confirmation of the absence of EGFR sensitizing mutations or ALK gene rearrangements from tumor tissue is required prior to enrollment.
- •Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.
- •No prior systemic anti-tumor therapy for the studied disease.
- •At least one measurable non-CNS lesion according to RECIST v1.1 criteria.
- •Adequate function of major organs.
排除标准
- •Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
- •Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.
- •Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
- •Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
- •subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.
- •Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.
- •Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.
- •History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.
- •A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.
- •A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.
- •The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.
- •A history of esophageal/gastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and/or fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive intestinal resection within 6 months prior to the first dose.
- •A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.
- •The presence of other malignant tumors.
- •Toxicities from prior neoadjuvant/adjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-
- •Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.
- •Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV antibody; e) active hepatitis B or C; f) known active syphilis.
- •Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..
- •Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
- •A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease
- •A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.
- •Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.
- •Pregnancy or lactation in female subjects.
- •A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.
- •Tumor-induced conditions or symptoms associated with a high medical risk.
- •Any other condition deemed by the investigator to be inappropriate for enrollment.
研究组 & 干预措施
SCTB14
Experimental
intravenous infusion on Day 1 of each 3-week cycle
干预措施: SCTB14 (Drug)
Pembrolizumab
Active Comparator
200mg, intravenous infusion on Day 1 of each 3-week cycle
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review
时间窗: Up to approximately 1.5 years
Time from randomization to first documented progression or death (whichever occurs first).
次要结局
- overall survival(Up to approximately 5 years)
- Progression-Free Survival (PFS) as Assessed by Investigator(Up to approximately 1.5 years)
- Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Central Review(Up to approximately 1.5 years)
- Disease Control Rate (DCR) Assessed by Blinded Independent Central Review(Up to approximately 1.5 years)
- Duration of Response （DOR）Assessed by Blinded Independent Central Review(Up to approximately 1.5 years)
- Time to Response (TTR)(Up to approximately 1.5 years)
- Treatment-Emergent Adverse Event（TEAE）(The first dose of study drug until 30 days (±7 days) after the last dose)
- Serious adverse events (SAEs)(From the first dose of study druguntil 60 days after the last dose.)
- immune-related adverse events (irAEs)(From the first dose of study druguntil 60 days after the last dose)
- PD-L1 expression(Up to approximately 1.5 years.)
- Quality of Life Questionnaire(Up to approximately 1.5 years.)
- Quality of Life Questionnaire(Up to approximately 1.5 years)
- Anti-drug antibodies (ADA)(Up to approximately 1.5 years)
- Pharmacokinetic (PK)(Up to approximately 1.5 years.)
研究者
研究点 (1)
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