Taking people in ChinaPhase 2
Tests SKB571 combination therapy in lung cancer
Tests SKB571 with other drugs in adults with non-small cell lung cancer.
Key facts
- Who runs it
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Where
- Beijing, Changchun, Changsha, Chengdu, Chongqing, Dongguan, Fuzhou, Guangzhou, Guilin, Hangzhou, Harbin, Jinan, Kunming, Nanchang, Nanjing, Nanning, Shenyang, Taiyuan, Tianjin, Ürümqi, Xi’an, Xiamen, Xiangyang, and Zhengzhou, ChinaSee the 27 sites
- Trial code
- Registry title
- A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 150 people, planned
- Started
- 15 Jul 2026
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- SKB571 for injection
- Osimertinib
- Furmonertinib
- carboplatin
- Cisplatin
- Pembrolizumab
- Record updated
- 2 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer that has been confirmed by tissue or cell tests and can be measured on scans.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Non-small cell lung cancer confirmed by tissue or cell tests, with at least one lesion that can be measured (RECIST v1.1).
- Earlier treatment
- Side effects from earlier anti-cancer treatment must have cleared.
Main reasons for not taking part
- Other cancer within 3 years before the first dose
- Active or untreated cancer spread to the brain or spinal cord
- History of interstitial lung disease or non-infectious pneumonitis
- Past organ transplant or donor stem-cell transplant
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current uncontrolled concomitant diseases
- Unresolved toxicity from prior anti-tumor therapy
- Serious infection within 4 weeks before the first dose of study treatment
- 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
- Participants with other malignant tumors within 3 years before the first dose of study treatment
- 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
- Known active pulmonary tuberculosis
- Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial
- Active or untreated central nervous system (CNS) metastasis
- Pregnant or breastfeeding women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Peking University Cancer HospitalBeijing, ChinaContact: Jian Fang (principal investigator)Not yet recruiting
- Jilin Cancer HospitalChangchun, ChinaContact: Haifeng Liu (principal investigator)Not yet recruiting
- Hunan Cancer HospitalChangsha, ChinaContact: Bolin Chen (principal investigator)Not yet recruiting
- Sichuan Cancer Hospital & InstituteChengdu, ChinaContact: Wenxiu Yao (principal investigator)Not yet recruiting
- West China Hospital，Sichuan UniversityChengdu, ChinaContact: Guowei Che (principal investigator)Not yet recruiting
- Xinqiao Hospital of Army Medical UniversityChongqing, ChinaContact: Zhi Xu (principal investigator)Not yet recruiting
- Dongguan People's HospitalDongguan, ChinaContact: Guanming Jiang (principal investigator)Not yet recruiting
- Fujian Provincial Cancer HospitalFuzhou, ChinaContact: Jing Zhang (principal investigator)Not yet recruiting
- Guangzhou Medical University First Affiliated HospitalGuangzhou, ChinaContact: Chengzhi Zhou (principal investigator)Taking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Li Zhang (principal investigator)Taking people
- Guilin Medical University First Affiliated HospitalGuilin, ChinaContact: Yanyi Zhao (principal investigator)Not yet recruiting
- Zhejiang Cancer HospitalHangzhou, ChinaContact: Xinmin Yu (principal investigator)Not yet recruiting
- Harbin Medical University Cancer HospitalHarbin, ChinaContact: Yan Yu (principal investigator)Not yet recruiting
- Shandong Cancer HospitalJinan, ChinaContact: Haiyong Wang (principal investigator)Not yet recruiting
- Yunnan Cancer HospitalKunming, ChinaContact: Runxiang Yang (principal investigator)Not yet recruiting
- Jiangxi Cancer HospitalNanchang, ChinaContact: Zhentian Liu (principal investigator)Not yet recruiting
- Jiangsu Province HospitalNanjing, ChinaContact: Wangjian Zha (principal investigator)Not yet recruiting
- Guangxi Medical University Affiliated Tumor HospitalNanning, ChinaContact: Yun Zhao (principal investigator)Not yet recruiting
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaContact: Wei Zheng (principal investigator)Not yet recruiting
- Shanxi Cancer hospitalTaiyuan, ChinaContact: Wei Guo (principal investigator)Not yet recruiting
- Tianjin Cancer HospitalTianjin, ChinaContact: Liuchun Wang (principal investigator)Not yet recruiting
- Xinjiang Medical University Affiliated Tumor HospitalÜrümqi, ChinaContact: Chunling Liu (principal investigator)Not yet recruiting
- The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaContact: Yu Yao (principal investigator)Not yet recruiting
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Jingxun Wu (principal investigator)Not yet recruiting
- Xiangyang Central HospitalXiangyang, ChinaContact: Tienan Yi (principal investigator)Not yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaContact: Qiming Wang (principal investigator)Not yet recruiting
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Siyuan Huang (principal investigator)Not yet recruiting
About the trial
What the trial wants to find out
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).
The 3 groups in the trial
- NSCLC with sensitive EGFR mutationsTreatment being tested
Treatment: SKB571 for injection, Osimertinib, and Furmonertinib
- NSCLC with EGFR wild-typeTreatment being tested
Treatment: SKB571 for injection, carboplatin, Cisplatin, and Pembrolizumab
- NSCLC with uncommon EGFR mutationsTreatment being tested
Treatment: SKB571 for injection, Furmonertinib, carboplatin, and Cisplatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Plain-language title
- Tests SKB571 combination therapy in lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07622186, who can take part
- Record updated
- 2 September 2026