A Randomized, Double-blind, Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative, Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients
概览
- 阶段
- 3 期
- 干预措施
- QL1706
- 疾病 / 适应症
- Lung Cancer
- 发起方
- Qilu Pharmaceutical Co., Ltd.
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- OS
- 状态
- 进行中（未招募）
- 最后更新
- 5个月前
概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy in PD-L1 negative, locally advanced or metastatic Non-small Cell Lung Cancer Patients. The subjects were randomly divided into two groups according to 1:1, with about 304 subjects in the experimental group and the control group.
详细描述
This study was a randomized, double-blind, active-controlled, multicenter Phase 3 clinical study. The study is designed to evaluate the efficacy and safety of QL1706 in combination with chemotherapy or commercial PD1 in combination with chemotherapy in locally advanced or metastatic NSCLC patients who are PD-L1 negative.608 patients would be enrolled . Subjects will be assigned randomly in a 1:1 ratio to experimental group and control group. Subjects will be stratified by pathological type: squamous cell carcinoma versus non-squamous cell carcinoma; brain metastasis: present versus absent; gender: male versus female. After randomization, subjects will be treated according to the randomization results.
研究者
入排标准
入选标准
- •Be≥18 to ≤ 75 years of age at enrollment, male or female.
- •Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
- •No EGFR sensitive mutations or ALK gene translocation alterations.
- •Capable of providing fresh or archived 2 years' tissue samples collected at post-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1 testing with TPS \< 1% .
- •Have a life expectancy of at least 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •No prior systemic therapy for advanced or metastatic NSCLC was received.
排除标准
- •Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugs acting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpoint agonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies, etc.), and immune cell therapy.
- •Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose.
- •Presence or history of any active autoimmune disease, including, but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism.
- •Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose;
- •Palliative radiotherapy completed 7 days prior to first dose.
- •Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening.
- •Clinically significant cardiovascular or cerebrovascular disease
研究组 & 干预措施
QL1706+chemotherapy
Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive QL1706, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 or QL1706 combined with pemetrexed.
干预措施: QL1706
Tiselizumab+chemotherapy
Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive tiselizumab, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with tiselizumab or tiselizumab combined with pemetrexed.
干预措施: Tilesizumab
结局指标
主要结局
OS
时间窗: From date of randomization until the date of death from any cause, which ever came first, assessed up to 2 years
Overall Survival (OS) in the ITT population determined by the investigator
次要结局
- ORR(First administration until disease progression or death, which ever occurs first (up to approximately 24 months))
- DOR(First administration until disease progression or death, which ever occurs first (up to approximately 24 months))
- DCR(First administration until disease progression or death, which ever occurs first (up to approximately 24 months))
- PFS(Informed consent until disease progression or death, which ever occurs first (up to approximately 2 years))