A Prospective, Exploratory, Two-Arm Study of Adebrelimab Maintenance Therapy in Limited-Stage Small Cell Lung Cancer Following Either Induction Chemo-Adebrelimab Plus Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Alone
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for Limited-Stage Small Cell Lung Cancer
详细描述
The study comprises two cohorts (A and B). Cohort A first receives two cycles of induction therapy combining PD-L1 inhibitors with chemotherapy, followed by two cycles of concurrent chemoradiotherapy and subsequent maintenance therapy with PD-L1 inhibitors. Cohort B first undergoes four cycles of concurrent chemoradiotherapy followed by maintenance therapy with PD-L1 inhibitors. Both cohorts continue treatment until disease progression or intolerable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old, male or female;
- •Patients with pathologically confirmed localized small cell lung cancer (as defined by the Veterans Administration Lung Study Group, VALG staging);
- •No anticipated need for tumor resection during the study period (including patients unsuitable for surgery or unwilling to undergo surgery);
- •No prior treatment for localized small cell lung cancer;
- •Presence of measurable tumor target lesions (meeting RECIST 1.1 criteria);
- •Expected survival > 3 months;
- •ECOG PS: 0-1;
- •Normal major organ function;
- •Complete blood count (CBC) (without transfusion or hematopoietic growth factor correction within 14 days):
- •Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 100 × 10⁹/L; White blood cell count (WBC) ≥ 3.0 × 10⁹/L;
- •Biochemical tests:
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for subjects with Gilbert syndrome); Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min;
- •Coagulation function:
- •Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin time (PT) ≤ 1.5×ULN;
- •Doppler ultrasound assessment:
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Women of childbearing potential must have a negative pregnancy test (βHCG) prior to treatment initiation. Women of childbearing potential and males (who have sexual intercourse with women of childbearing potential) must agree to use effective contraception continuously during treatment and for 6 months after the last dose.
- •Patients voluntarily participate in this study and sign an informed consent form.
排除标准
- •Mixed SCLC and extensive-stage SCLC;
- •History of other malignancies within the past 5 years or concurrent malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial or non-invasive bladder cancer;
- •History of uncontrollable psychiatric disorders or severe intellectual or cognitive impairment;
- •Active, known, or suspected autoimmune disease; however, subjects with hypothyroidism requiring only hormone replacement therapy or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are eligible;
- •Subjects with any severe and/or uncontrolled medical conditions, including:
- •Subjects with uncontrolled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
- •Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including male QTc ≥ 450 ms or female QTc ≥ 470 ms), and ≥ Grade 2 congestive heart failure (New York Heart Association [NYHA] classification);
- •Severe unhealed wounds, ulcers, or fractures;
- •History of psychiatric drug abuse, alcoholism, or illicit drug use;
- •Active hepatitis (HBV reference: HBsAg positive with HBV DNA levels exceeding upper normal limit; HCV reference: HCV antibody positive with HCV viral load exceeding upper normal limit);
- •Human Immunodeficiency Virus (HIV, HIV 1/2 antibody) positive;
- •Patients unable to comply with the study protocol or participate in follow-up visits;
- •Patients deemed unsuitable for this trial by the investigator.
研究组 & 干预措施
Adebrelimab Induction Therapy Group
Induction Phase adebrelimab combined with etoposide and platinum-based chemotherapy Concurrent Chemoradiotherapy Phase Radiotherapy initiated prior to the third cycle of chemotherapy, no later than the start of the third cycle, combined with etoposide and platinum-based chemotherapy Maintenance Phase adebrelimab administered until disease progression, intolerable toxicity, or a maximum of 2 years of treatment.
干预措施: Adebrelimab Induction Therapy Group (Drug)
Adebrelimab Maintenance Therapy Group
Radiotherapy is initiated prior to the third cycle of chemotherapy, no later than the start of the third cycle, in combination with etoposide and platinum-based agents.
Maintenance Phase adebrelimab is administered until disease progression, intolerable toxicity, or a maximum of 2 years of treatment.
干预措施: Adebrelimab Maintenance Therapy Group (Drug)
结局指标
主要结局
PFS
时间窗: through study completion, an average of 3 years
From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first
次要结局
- ORR(through study completion, an average of 3 years)
- OS(through study completion, an average of 3 years)
- Adverse Events(From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment)
- DCR(through study completion, an average of 3 years)
研究者
Minglei Zhuo
Chief Physician
Peking University Cancer Hospital & Institute