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 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: SKB264-II-04MK-2870-0032023-507270-41-00
• Study Type: interventional
• Target: 356
• Locations: 6 countries
• Sites: 50

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability

  Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs

  From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months

• ORR

  Objective response rate (ORR) per RECIST v1.1

  The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months

Secondary Outcomes (3)

• Duration of response (DOR)

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months

• Progression-free survival (PFS)

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months

• Overall survival (OS)

  From baseline until death due to any cause, up to approximately 36 months

Study Arms (8)

Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%

EXPERIMENTAL

SKB264 (Dose Level 1) + Pembrolizumab

Drug: SKB264; Drug: Pembrolizumab

Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level

EXPERIMENTAL

SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin

Drug: SKB264; Drug: Pembrolizumab; Drug: Carboplatin

Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level

EXPERIMENTAL

SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin

Drug: SKB264; Drug: Pembrolizumab; Drug: Carboplatin

Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy

EXPERIMENTAL

SKB264 (Dose Level 1') + Carboplatin

Drug: SKB264; Drug: Carboplatin

Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy

EXPERIMENTAL

SKB264 (Dose Level 1'') + Carboplatin

Drug: SKB264; Drug: Carboplatin

Cohort 7 1L NSCLC with EGFR mutation

EXPERIMENTAL

SKB264 (Dose Level 1) + Osimertinib

Drug: SKB264; Drug: Osimertinib

Cohort 7-1 1L NSCLC with EGFR mutation

EXPERIMENTAL

SKB264 (Dose Level 2) + Osimertinib

Drug: SKB264; Drug: Osimertinib

Cohort 9 2/3L NSCLC EGFR/ALK negative

EXPERIMENTAL

SKB264 (Dose Level 1)

Drug: SKB264

Interventions

SKB264 DRUG

intravenous (IV) infusion (Q2W or Q3W)

Also known as: MK-2870, Sacituzumab Tirumotecan (Sac-TMT)

Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%; Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level; Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level; Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy; Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy; Cohort 7 1L NSCLC with EGFR mutation; Cohort 7-1 1L NSCLC with EGFR mutation; Cohort 9 2/3L NSCLC EGFR/ALK negative

Pembrolizumab DRUG

intravenous (IV) infusion (400mg, Q6W)

Also known as: MK-3475

Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%; Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level; Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level

Carboplatin DRUG

intravenous (IV) infusion (AUC5, Q3W)

Also known as: Carboplatin for injection

Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level; Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level; Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy; Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy

Osimertinib DRUG

80mg, QD

Also known as: Osimertinib Mesylate

Cohort 7 1L NSCLC with EGFR mutation; Cohort 7-1 1L NSCLC with EGFR mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender;
• Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ;
• 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;
• 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;
• Subjects are able to provide tumor blocks or slides before the first dose of study intervention;
• Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria;
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1;
• Life expectancy at least 3 months for the subject;
• Adequate organ function;
• Subjects must have recovered from all toxicities led by prior treatment;
• Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects;
• Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

You may not qualify if:

• Subjects with mixed SCLC histopathological features;
• Subjects with a known history of prior malignancy;
• Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases;
• Subjects with ≥ Grade 2 peripheral neuropathy;
• 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;
• Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease;
• Subjects who suffer from cardiovascular diseases of clinical significance;
• Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids;
• Subjects with uncontrolled systemic disease as judged by the Investigator;
• Subjects with active autoimmune disease that required systemic treatment in the past 2 years;
• Subjects with active hepatitis B or hepatitis C;
• Subjects with known history of Human Immunodeficiency Virus (HIV)
• Subjects with known active tuberculosis;
• Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;

Sponsors & Collaborators

• Klus Pharma Inc.: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator

Study Sites (50)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Chongqing University Cancer Hospital (Chongqing Cancer Hospital)

Chongqing, Chongqing Municipality, 400000, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yatsen University Cancer Center Huangpu Hos

Guangzhou, Guangdong, 510700, China

Location

Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

The First Affiliated Hospital of Zhengzhou University(Heyi Compus)

Zhengzhou, Henan, 450052, China

Location

Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, 45008, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130021, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of Chinese Medical University(Heping Compus)

Shenyang, Liaoning, 110002, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 30009, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Chengdu Fifth People's Hospital

Chengdu, Sichuan, 611130, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

ISR-GEO Med Res Clin Healthycore

Tbilisi, 0112, Georgia

Location

LLC "Todua Clinic"

Tbilisi, 0112, Georgia

Location

Ltd New Hospitals

Tbilisi, 0114, Georgia

Location

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, Cluj, 400015, Romania

Location

Centrul de Oncologie Sf. Nectarie

Craiova, Dolj, 200542, Romania

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido, 16247, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 6351, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Hospital Universitario Puerta De Hierro De Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario QuirónSalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Micancer Center S.L.P.

Barcelona, 08017, Spain

Location

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, 08028, Spain

Location

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital Quironsalud Malaga

Málaga, 29004, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

Hospital Clinico Universitario De Valencia

Valencia, 46010, Spain

Location

Medical Park Seyhan Hospital

Adana, 01140, Turkey (Türkiye)

Location

Adana City Training and Research Hospital

Adana, 01370, Turkey (Türkiye)

Location

Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi

Ankara, 06010, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Carboplatin; Injections; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: April 19, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (5); GE (3); RO (2); CN (27); KR (5); ES (8)