A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 9, 2025

Primary Completion Date

August 30, 2026

Study Completion Date

January 9, 2029

Conditions
Non Small Cell Lung Cancer
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,at most 35 cycles

DRUG

Sintilimab

Intravenous infusion at a recommended dose of 200 mg once every 3 weeks,at most 35 cycles

DRUG

Pemetrexed

Intravenously at a recommended dose of 500 mg/m2 body surface area (BSA) ,once every 3 weeks until the disease progresses.

DRUG

Gemcitabine

1000 mg/m2, administered on Days 1 and 8 ,once every 3 weeks (Q3W) for 4 cycles

DRUG

Cisplatin Or Carboplatin

"Cisplatin: 5 mg/m2 administered intravenously every 3-4 weeks for 4 cycles~Carboplatin:75 mg/m2, administered intravenously every 3-4 weeks for 4 cycles"

Trial Locations (28)

Unknown

RECRUITING

Beijing Chest Hospital, Beijing

RECRUITING

Binzhou Medical University Hospital, Binzhou

RECRUITING

Sichuan Cancer Hospital, Chengdu

NOT_YET_RECRUITING

Chongqing University Three Gorges Hospital, Chongqing

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Ha’erbin

NOT_YET_RECRUITING

Anhui Provincial Cancer Hospital, Hefei

RECRUITING

The First Affiliated Hospital of Anhui Medical University, Hefei

RECRUITING

Jiangmen Central Hospital, Jiangmen

RECRUITING

Yunan Cancer Hospital, Kunming

RECRUITING

Linyi People's Hospital, Linyi

NOT_YET_RECRUITING

Lishui Central Hospital, Lishui

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

RECRUITING

Guangxi Medical University Cancer Hospital, Nanning

RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

RECRUITING

The Second People's Hospital of Neijiang, Neijiang

RECRUITING

Shanghai Chest Hospital, Shanghai

RECRUITING

First Hospital of Shanxi Medical University, Taiyuan

RECRUITING

Shanxi Provincial Cancer Hospital, Taiyuan

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

RECRUITING

Hubei Cancer Hospital, Wuhan

NOT_YET_RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

NOT_YET_RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

RECRUITING

Xiangyang Central Hospital, Xiangyang

NOT_YET_RECRUITING

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

NOT_YET_RECRUITING

The Second People's Hospital of Yibin, Yibin

NOT_YET_RECRUITING

General Hospital of Ningxia Medical University, Yinchuan

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

RECRUITING

Zhoukou Central Hospital, Zhoukou

All Listed Sponsors
lead

TJ Biopharma Co., Ltd.

INDUSTRY