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

Starting soon · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT07622186

Run by

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

People needed

150

Starts

2026-07-31

Expected to finish

2029-12-31

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
• Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks as assessed by the investigator.
• Adequate organ and bone marrow function.
• Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
• Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

You may not qualify if…

• Participants with other malignant tumors within 3 years before the first dose of study treatment.
• Active or untreated central nervous system (CNS) metastasis.
• Current uncontrolled concomitant diseases
• Clinically severe lung damage due to complications of lung disorder
• Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
• A history of severe skin diseases
• Unresolved toxicity from prior anti-tumor therapy
• Serious infection within 4 weeks before the first dose of study treatment
• Known active pulmonary tuberculosis.
• Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
• Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
• Pregnant or breastfeeding women.
• Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where it is running

• 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

Full record on ClinicalTrials.gov

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