A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Event Free Survival (EFS) in stage III NSCLC
研究概览
简要总结
This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
- •Age ≥ 18 years.
- •Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
- •Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).
- •Deemed radically resectable with curative intent.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.
排除标准
- •Subjects with confirmed or suspected brain metastases.
- •Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
- •Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization
- •Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
- •Requiring long term systemic corticosteroids
- •Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
- •Active hepatitis B.
研究组 & 干预措施
Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Pemetrexed (Drug)
Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Carboplatin (Drug)
Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Paclitaxel (Drug)
Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Sintilimab (Drug)
Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Cisplatin (Drug)
Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Nab paclitaxel (Drug)
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Pemetrexed (Drug)
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Carboplatin (Drug)
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Paclitaxel (Drug)
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Cisplatin (Drug)
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Nab paclitaxel (Drug)
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
干预措施: Placebo (Drug)
结局指标
主要结局
Event Free Survival (EFS) in stage III NSCLC
时间窗: Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event Free Survival (EFS) in ITT population
时间窗: Up to approximately 3 years following the beginning of Post-operative Assessment baseline(up to Study 3 years )
EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first.
次要结局
- Disease free survival (DFS)(Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years ))
- Major Pathological Response (mPR) Rat(Up to approximately 6 weeks following completion of neoadjuvant treatment (up to Study 2 years))
- Overall survival (OS)(Up to approximately 5.4 years)
- Safety parameters:AE(Up to approximately 5.4 years)