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Clinical Trials in China / NCT05816252
Active, not recruiting Phase 2

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

NCT05816252 · tracked via the Priya Life Science China tracker
Sponsor
Klus Pharma Inc.
Phase
Phase 2
Started
2023-04-19
Last updated
2026-01-27

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

SKB264 →Pembrolizumab →Carboplatin →Osimertinib →

SKB264: intravenous (IV) infusion (Q2W or Q3W)

Pembrolizumab: intravenous (IV) infusion (400mg, Q6W)

Carboplatin: intravenous (IV) infusion (AUC5, Q3W)

Osimertinib: 80mg, QD

Study summary

The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria 1. Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; 3. Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation; 4. Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment; 5. Subjects are able to provide tumor blocks or slides before the first dose of study intervention; 6. Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; 7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; 8. Life expectancy at least 3 months for the subject; 9. Adequate organ function; 10. Subjects must have recovered from all toxicities led by prior treatment; 11. Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; 12. Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria 1. Subjects with mixed SCLC histopathological features; 2. Subjects with a known history of prior malignancy; 3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; 4. Subjects with ≥ Grade 2 peripheral neuropathy; 5. Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome; 6. Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; 7. Subjects who suffer from cardiovascular diseases of clinical significance; 8. Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids; 9. Subjects with uncontrolled systemic disease as judged by the Investigator; 10. Subjects with active autoimmune disease that required systemic treatment in the past 2 years; 11. Subjects with active hepatitis B or hepatitis C; 12. Subjects with known history of Human Immunodeficiency Virus (HIV) 13. Subjects with known active tuberculosis; 14. Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; 16. Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; 17. Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality
Chongqing University Cancer Hospital (Chongqing Cancer Hospital) Chongqing Chongqing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Sun Yat-Sen University Cancer Center Guangzhou Guangdong
Sun Yatsen University Cancer Center Huangpu Hos Guangzhou Guangdong
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital Nanning Guangxi
Harbin Medical University Cancer Hospital Harbin Heilongjiang
The First Affiliated Hospital of Zhengzhou University(Heyi Compus) Zhengzhou Henan
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University Zhengzhou Henan
Zhongnan Hospital of Wuhan University Wuhan Hubei
Hubei Cancer Hospital Wuhan Hubei
Hunan Cancer Hospital Changsha Hunan
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
Jilin Cancer Hospital Changchun Jilin
The First Hospital of Jilin University Changchun Jilin
The First Hospital of Chinese Medical University(Heping Compus) Shenyang Liaoning
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
Shandong Cancer Hospital and Institute Jinan Shandong
Shanghai Chest Hospital Shanghai Shanghai Municipality
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Shanxi Provincial Cancer Hospital Taiyuan Shanxi
Sichuan Cancer Hospital Chengdu Sichuan
West China Hospital of Sichuan University Chengdu Sichuan
Chengdu Fifth People's Hospital Chengdu Sichuan
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
Zhejiang Cancer Hospital Hangzhou Zhejiang
ISR-GEO Med Res Clin Healthycore Tbilisi Georgia
LLC "Todua Clinic" Tbilisi Georgia
Ltd New Hospitals Tbilisi Georgia
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca Cluj-Napoca Cluj
Centrul de Oncologie Sf. Nectarie Craiova Dolj
The Catholic University of Korea, St. Vincent's Hospital Suwon Gyeonggido
Chungbuk National University Hospital Cheongju-si North Chungcheong
Samsung Medical Center Seoul Seoul Teugbyeolsi
Inje University Haeundae Paik Hospital Busan South Korea
Severance Hospital, Yonsei University Health System Seoul South Korea
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Madrid
Hospital Universitario QuirónSalud Madrid Pozuelo de Alarcón Madrid
Micancer Center S.L.P. Barcelona Spain

+ 10 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile → 📄 Tagrisso (osimertinib) drug profile →

More Klus Pharma Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05816252 on ClinicalTrials.gov ↗ ← All trials in China