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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: SKB571 for injection; Drug: Osimertinib; Drug: Furmonertinib; Drug: carboplatin; Drug: Cisplatin; Drug: Pembrolizumab

Detailed Description

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xin Li, MD; Phone Number: 86-13311373861; Email: lixin@kelun.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400037
      • Xinqiao Hospital of Army Medical University
      • Principal Investigator: Zhi Xu
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital
      • Principal Investigator: Jing Zhang
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University
      • Principal Investigator: Jingxun Wu
  • Guangdong
    • Dongguan, Guangdong, China, 523018
      • Dongguan People's Hospital
      • Principal Investigator: Guanming Jiang
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
      • Principal Investigator: Li Zhang
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Medical University First Affiliated Hospital
      • Principal Investigator: Chengzhi Zhou
  • Guangxi
    • Guilin, Guangxi, China, 541001
      • Guilin Medical University First Affiliated Hospital
      • Principal Investigator: Yanyi Zhao
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital
      • Principal Investigator: Qitao Yu
      • Principal Investigator: Yun Zhao
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
      • Principal Investigator: Yan Yu
      • Principal Investigator: Qingwei Meng
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
      • Principal Investigator: Qiming Wang
  • Hubei
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
      • Principal Investigator: Tienan Yi
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
      • Principal Investigator: Bolin Chen
      • Principal Investigator: Xingxiang Pu
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
      • Principal Investigator: Wangjian Zha
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
      • Principal Investigator: Zhentian Liu
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital
      • Principal Investigator: Haifeng Liu
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
      • Principal Investigator: Wei Zheng
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
      • Principal Investigator: Yan Zhang
      • Principal Investigator: Haiyong Wang
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Cancer Hospital
      • Principal Investigator: Wei Guo
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiao Tong University
      • Principal Investigator: Yu Yao
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
      • Principal Investigator: Guowei Che
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital & Institute
      • Principal Investigator: Wenxiu Yao
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Cancer Hospital
      • Principal Investigator: Liuchun Wang
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830011
      • Xinjiang Medical University Affiliated Tumor Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital
      • Principal Investigator: Runxiang Yang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
      • Principal Investigator: Xinmin Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
2. Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy ≥ 12 weeks as assessed by the investigator.
6. Adequate organ and bone marrow function.
7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
8. 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:

1. Participants with other malignant tumors within 3 years before the first dose of study treatment.
2. Active or untreated central nervous system (CNS) metastasis.
3. Current uncontrolled concomitant diseases
4. Clinically severe lung damage due to complications of lung disorder
5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
6. A history of severe skin diseases
7. Unresolved toxicity from prior anti-tumor therapy
8. Serious infection within 4 weeks before the first dose of study treatment
9. Known active pulmonary tuberculosis.
10. 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.
11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
12. Pregnant or breastfeeding women.
13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NSCLC with sensitive EGFR mutations	Drug: SKB571 for injection; Intravenous(IV) infusion(Q3W); Drug: Osimertinib; orally once daily; Drug: Furmonertinib; orally once daily
Experimental: NSCLC with EGFR wild-type	Drug: SKB571 for injection; Intravenous(IV) infusion(Q3W); Drug: carboplatin; Intravenous(IV) infusion(Q3W); Drug: Cisplatin; Intravenous(IV) infusion(Q3W); Drug: Pembrolizumab; Intravenous(IV) infusion(Q3W)
Experimental: NSCLC with uncommon EGFR mutations	Drug: SKB571 for injection; Intravenous(IV) infusion(Q3W); Drug: Furmonertinib; orally once daily; Drug: carboplatin; Intravenous(IV) infusion(Q3W); Drug: Cisplatin; Intravenous(IV) infusion(Q3W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	Up to approximately 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)		Up to approximately 36 months
Safety and tolerability	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.	Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC	Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma	Up to approximately 36 months
Immunogenicity	Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum	Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC	Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma	Up to approximately 36 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb	Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma	Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb	Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma	Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348	Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma	Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348	Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma	Up to approximately 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between biomarkers and efficacy	To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy	Up to approximately 36 months

Collaborators and Investigators

• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
• Investigators: Study Director: Xin Li, MD, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Therapeutics; Drug Administration Routes; Drug Therapy; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Carboplatin; Cisplatin; Injections; pembrolizumab; osimertinib; aflutinib
• Other Study ID Numbers: SKB571-II-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No