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RECRUITING
NCT07622186
PHASE2

A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-07-15

Completion Date

2029-12-31

Last Updated

2026-09-02

Healthy Volunteers

No

Interventions

DRUG

SKB571 for injection

Intravenous(IV) infusion(Q3W)

DRUG

Osimertinib

orally once daily

DRUG

Furmonertinib

orally once daily

DRUG

carboplatin

Intravenous(IV) infusion(Q3W)

DRUG

Cisplatin

Intravenous(IV) infusion(Q3W)

DRUG

Pembrolizumab

Intravenous(IV) infusion(Q3W)

Locations (27)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangzhou Medical University First Affiliated Hospital

Guangzhou, Guangdong, China

Guilin Medical University First Affiliated Hospital

Guilin, Guangxi, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Affiliated Tumor Hospital

Ürümqi, Xinjiang Uygur Autonomous Region, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China