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ACTIVE NOT RECRUITING
NCT06984588
PHASE2/PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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,

DRUG

Toripalimab

240 mg on Day 1, once every 3 weeks (Q3W)

DRUG

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