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A Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer
Sponsor: TJ Biopharma Co., Ltd.
Summary
This is a Phase II/III, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with toripalimab, toripalimab monotherapy, and pembrolizumab monotherapy in patients with previously untreated locally advanced unresectable or metastatic PD-L1-positive (tumor proportion score \[TPS\] ≥ 1%) and CD73-positive (TC/IC \> 30%; TC/IC defined as the higher of either the proportion of CD73-positive tumor cells or the proportion of CD73-positive immune cells at any intensity \[IHC1+ or above\]) NSCLC who are not suitable for targeted therapies such as EGFR, ALK, etc. The number of enrolled subjects with PD-L1 TPS ≥ 50% will be limited to approximately 60% of the total sample size to reflect the natural prevalence of advanced NSCLC. Patients who have received adjuvant or neoadjuvant therapy other than immune checkpoint inhibitor treatments are allowed to participate in this study, provided that such treatments have been completed at least 12 months prior to the occurrence of recurrence or metastasis. During the screening period, tumor samples will be collected in advance and tested by the central laboratory for PD-L1 expression levels using the PD-L1 IHC 22C3 pharmDx assay and CD73 expression levels using the CD73 antibody assay (immunohistochemistry). Previous PD-L1 testing results obtained using the PD-L1 IHC 22C3 pharmDx assay will be accepted. Patients with PD-L1 positive expression (TPS ≥ 1%) and high CD73 expression (TC/IC \> 30%) will meet the inclusion criteria. Patients who do not meet the eligibility criteria as judged by the investigator may be re-screened once. Patients with non-squamous NSCLC will be required to confirm the absence of EGFR-sensitive mutations or ALK fusion; patients with unknown EGFR and ALK expression status will be required to undergo testing and provide clinical laboratory test results prior to study enrollment, and may be enrolled after relevant driver gene mutations are ruled out. Meanwhile, patients with other definite actionable driver gene alterations (such as: ROS1 fusions, RET fusions, NTRK1/2/3 fusions, BRAF V600E mutations, MET14 exon skipping mutations, etc.) will be excluded from this study. Controversial cases with actionable gene mutations will be submitted to the study expert panel for joint decision. This study includes Phase II and Phase III stages. Approximately 150 subjects will be enrolled in the Phase II stage. Based on the evaluation of the efficacy, safety, PK, and PD results of the Phase II study, a decision will be made on whether to proceed to the Phase III study. Approximately 300 subjects will be enrolled in the Phase III stage.
Official title: A Phase II/III, Randomized, Multicenter, Open-Label Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-03-28
Completion Date
2028-09-30
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
Uliledlimab
30 mg/kg, administered on Days 1 and 8 of Cycle 1 (C1D1 and C1D8), then once every 3 weeks (Q3W) starting from C2D1,
Toripalimab
240 mg on Day 1, once every 3 weeks (Q3W)
Pembrolizumab
200 mg on Day 1, once every 3 weeks (Q3W)
Locations (64)
Anyang Tumour Hospital
Anyang, China
Beijing Chest Hospital, Capital Medical University
Beijing, China
Bejing Chao-Yang Hospital, Capital Medical University
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
Binzhou Medical University Hospital
Binzhou, China
The Third Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital of Central South University
Changsha, China
Army characteristic Hospital Center( Daping Hospital of the Third Military Medical University)
Chongqing, China
Chongqing University Cancer Hospital
Chongqing, China
Chongqing University Three Gorges Hospital
Chongqing, China
The People's Hospital of Dongguan
Dongguan, China
The first people's hospital of Foshan
Foshan, China
First Affiliated Hospital of Gannan Meidcal University
Ganzhou, China
Ganzhou People's Hospital
Ganzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, China
Harbin Medical university cancer hospital
Ha’erbin, China
Anhui provincial cancer hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Jiamusi Tumour Hospital
Jiamusi, China
Jiangmen Central hospital
Jiangmen, China
Jinan Central Hospital
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Linyi People's Hospital
Linyi, China
Lishui Central Hospital
Lishui, China
Liuzhou Central Hospital
Liuchow, China
Longyan First Hospital
Longyan, China
Jiangxi Cancer Hospital
Nanchang, China
The First Affiliated Hospital Of Nanchang University
Nanchang, China
Nanchong Central Hospital
Nanchong, China
Jiangsu Province Hospital
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Nantong Tumor Hospital
Nantong, China
Nanyang Cenreal Hospital
Nanyang, China
The Second People's Hospital of Neijiang
Neijiang, China
Qingdao Central Hospital
Qingdao, China
The First People's Hospital Of Qujing
Qujing, China
Yuebei People's Hospital
Shaoguan, China
China Shenyang the Tenth People's Hospital(China Shenyang Chest Hospital)
Shenyang, China
The Fourth Hospital Of Hebei Medical University
Shijia Zhuang, China
Suining Central Hospital
Suining, China
First Hospital of Shanxi Medical University
Taiyuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, China
Xi'an Chest Hospital
Xi'an, China
Fujian Provincial Cancer Hospital
Xiamen, China
The First Affiliated Hospital Of Xiamen University
Xiamen, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, China
Xiangyang Central Hospital
Xiangyang, China
Northern Jiangsu People's Hospital
Yangzhou, China
The Second People's Hospital Of Yibin
Yibin, China
Yichang Central People's Hospital
Yichang, China
Shanxi Yuncheng Central hospital
Yuncheng, China
The First Affiliated Hospital Of Henan University Of Science & Technology
Zhengzhou, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, China
Zhoukou Central hospital
Zhoukou, China
Zhujiang hospital of Southern Medical University
Zhujiang, China
Zibo Municipal Hospital
Zibo, China
The first people's hospital of Zunyi
Zunyi, China