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)
NCT ID: NCT05816252
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
356 participants
INTERVENTIONAL
2023-04-19
2026-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%
SKB264 (Dose Level 1) + Pembrolizumab
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)
Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)
Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
SKB264 (Dose Level 1') + Carboplatin
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
SKB264 (Dose Level 1'') + Carboplatin
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
Cohort 7 1L NSCLC with EGFR mutation
SKB264 (Dose Level 1) + Osimertinib
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Osimertinib
80mg, QD
Cohort 7-1 1L NSCLC with EGFR mutation
SKB264 (Dose Level 2) + Osimertinib
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Osimertinib
80mg, QD
Cohort 9 2/3L NSCLC EGFR/ALK negative
SKB264 (Dose Level 1)
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Interventions
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SKB264
intravenous (IV) infusion (Q2W or Q3W)
Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)
Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
Osimertinib
80mg, QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
INDUSTRY
Klus Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yatsen University Cancer Center Huangpu Hos
Guangzhou, Guangdong, China
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
Zhengzhou, Henan, China
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of Chinese Medical University(Heping Compus)
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital,The Third Affiliated Hospital of Kunming Medical University ,Yunnan Cancer Center
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
ISR-GEO Med Res Clin Healthycore
Tbilisi, , Georgia
LLC "Todua Clinic"
Tbilisi, , Georgia
Ltd New Hospitals
Tbilisi, , Georgia
Tbilisi St Med U Ingorokva High Med
Tbilisi, , Georgia
LTD Institute of Clinical Oncology
Tbilisi, , Georgia
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Cluj, Romania
Medisprof
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, Romania
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
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, Spain
Hospital Universitario QuirónSalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Micancer Center S.L.P.
Barcelona, , Spain
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital Quironsalud Malaga
Málaga, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Medical Park Seyhan Hospital
Adana, , Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, , Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara Liv Hospital Tibbi Onkoloji
Ankara, , Turkey (Türkiye)
Inonu University Turgut Ozal Medical Center
Malatya, , Turkey (Türkiye)
Countries
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Other Identifiers
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MK-2870-003
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507270-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
SKB264-II-04
Identifier Type: -
Identifier Source: org_study_id
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