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ACTIVE NOT RECRUITING
NCT07005336
PHASE2

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

Sponsor: TJ Biopharma Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase II, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with sintilimab and chemotherapy versus sintilimab combined with chemotherapy in patients with previously untreated locally advanced unresectable or metastatic NSCLC who are not suitable for targeted therapies such as EGFR or ALK. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either uliledlimab combined with sintilimab and chemotherapy or sintilimab combined with chemotherapy. Enrolled subjects will first enter a safety run-in period. When at least 12 subjects have been randomly assigned to Group A and have received ≥ 1 dose of study drug (with a total of approximately 24 subjects), enrollment will be suspended for safety evaluation. The safety evaluation period will last 3 weeks, during which safety, tolerability, and PK data of uliledlimab combined with sintilimab and chemotherapy will be collected and evaluated by the Safety Review Committee (SRC). The SRC will decide through discussion whether to proceed to the next stage of randomized enrollment, whether additional subjects need to be enrolled for safety evaluation, or whether the study treatment should be terminated due to high safety risks. After the SRC reaches a unanimous resolution, enrollment will continue until a total of approximately 150 subjects are enrolled. All 150 subjects will be included in the final efficacy analysis. If 3 or more subjects experience Grade ≥ 3 treatment-related AEs that are unrelieved and lead to discontinuation of all study drugs during the safety run-in period, enrollment in the next stage will be terminated.

Official title: A Phase II, Randomized, Multicenter, Open-Label 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-01-09

Completion Date

2029-01-09

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,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

Locations (28)

Beijing Chest Hospital

Beijing, China

Binzhou Medical University Hospital

Binzhou, China

Sichuan Cancer Hospital

Chengdu, China

Chongqing University Three Gorges Hospital

Chongqing, 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

Jiangmen Central Hospital

Jiangmen, China

Yunan Cancer Hospital

Kunming, China

Linyi People's Hospital

Linyi, China

Lishui Central Hospital

Lishui, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Guangxi Medical University Cancer Hospital

Nanning, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

The Second People's Hospital of Neijiang

Neijiang, China

Shanghai Chest Hospital

Shanghai, China

First Hospital of Shanxi Medical University

Taiyuan, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Hubei Cancer Hospital

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

Xiangyang Central Hospital

Xiangyang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

The Second People's Hospital of Yibin

Yibin, China

General Hospital of Ningxia Medical University

Yinchuan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zhoukou Central Hospital

Zhoukou, China