A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
Recruiting · NCT07622186 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
27 locations listed.
- 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