A Randomized Controlled Clinical Study of Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a randomized, controlled, multicenter clinical study that enrolled patients with unresectable bulky stage III NSCLC, with PFS as the primary endpoint. The study aims to investigate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of locally advanced/unresectable stage III non-small cell lung cancer.
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
- 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
- •Aged between 18 and 75 years;
- •ECOG performance status score of 0 or 1;
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
- •Unresectable stage III NSCLC (per AJCC 9th edition staging), with primary tumor diameter T ≥ 5 cm or regional metastatic lymph node short-axis diameter N ≥ 2 cm;
- •Expected survival time of at least 3 months;
- •No prior anti-tumor treatment before enrollment, including radiotherapy, chemotherapy, surgery and targeted therapy;
- •Adequate function of major organs;
- •Female subjects must have a negative pregnancy test result and be willing to use effective contraception;
- •Subjects voluntarily participate in the study, sign the informed consent form, with good compliance and willingness to complete follow-up.
排除标准
- •Subjects with known positive EGFR mutation or positive ALK fusion.
- •Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma.
- •Participation in another clinical trial within 4 weeks prior to the first study dose or within 5 half-lives of the study drug, whichever is shorter.
- •Subjects who have received systemic immunosuppressive therapy within 2 weeks before the first dose, or those who are expected to require systemic immunosuppressive drugs during the study treatment period.
- •Subjects with congenital or acquired immunodeficiency, such as HIV infection; or with a history of autoimmune diseases.
- •Active hepatitis B, hepatitis C, or co-infection with both hepatitis B and hepatitis C.
- •Uncontrolled third-space effusions, such as massive pleural effusion, ascites or pericardial effusion.
- •History of other malignant tumors (other than NSCLC) within 5 years prior to screening.
- •Subjects with prior interstitial lung disease requiring hormone therapy.
- •Subjects with severe cardiovascular and cerebrovascular diseases.
- •History of severe bleeding events or arterial/venous thromboembolic events.
- •Severe infection within 4 weeks before the first dose; evidence of active tuberculosis infection within 1 year prior to the first dose; active fungal, bacterial and/or viral infections requiring systemic treatment.
- •Subjects with prior or planned allogeneic bone marrow transplantation or solid organ transplantation.
- •History of live attenuated vaccination within 28 days before the first dose, or planned live attenuated vaccination during the study period; pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptive measures.
- •Known hypersensitivity, anaphylactic reaction or intolerance to adebrelimab, chemotherapy agents, or their excipients.
- •Subjects with a known history of psychoactive substance abuse, alcoholism or drug addiction.
研究组 & 干预措施
After chemoimmunotherapy induction followed by cCRT/sCRT, then maintenance immunotherapy.
Patients receive adebrelimab(1200 mg iv, q3w) combined with chemotherapy for 2 cycles of induction therapy, followed by sequential/concurrent chemoradiotherapy (sCRT/cCRT), and then undergo adebrelimab monotherapy for consolidation treatment.
干预措施: After chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy. (Drug)
Receive cCRT/sCRT followed by maintenance immunotherapy.
Adebrelimab monotherapy consolidation is administered after sCRT/cCRT.
干预措施: adebrelimab,Radiation Therapy,Radiotherapy (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment to the end of monitoring at 1.5 years.
PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment.
次要结局
- Overall Survival (OS)(From enrollment to the end of monitoring at 1.5 years.)
- Objective Response Rate (ORR)(From enrollment to the end of monitoring at 1.5 years.)
- Duration of Response (DoR)(From enrollment to the end of monitoring at 1.5 years.)
- The incidence of adverse events(From enrollment to the end of monitoring at 1.5 years)
- Time to Death or Distant Metastasis（TTDM）(From enrollment to the end of monitoring at 1.5 years)
研究者
Zhijie Wang
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences