Trial Title:
A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
NCT ID:
NCT05816252
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Osimertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SKB264
Description:
intravenous (IV) infusion (Q2W or Q3W)
Arm group label:
Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%
Arm group label:
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
Arm group label:
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
Arm group label:
Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
Arm group label:
Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
Arm group label:
Cohort 7 1L NSCLC with EGFR mutation
Arm group label:
Cohort 7-1 1L NSCLC with EGFR mutation
Arm group label:
Cohort 9 2/3L NSCLC EGFR/ALK negative
Other name:
MK-2870
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
intravenous (IV) infusion (400mg, Q6W)
Arm group label:
Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%
Arm group label:
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
Arm group label:
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
Other name:
MK-3475
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
intravenous (IV) infusion (AUC5, Q3W)
Arm group label:
Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
Arm group label:
Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level
Arm group label:
Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
Arm group label:
Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy
Other name:
Carboplatin for injection
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
80mg, QD
Arm group label:
Cohort 7 1L NSCLC with EGFR mutation
Arm group label:
Cohort 7-1 1L NSCLC with EGFR mutation
Other name:
Osimertinib Mesylate
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.
Detailed description:
This is a multicenter, open-label study of SKB264 as combination therapy in subjects with
NSCLC. Approximately up to 296 subjects will be enrolled in this study including around
36 (may expand) subjects for safety run-in period and 200 subjects for expansion period.
Criteria for eligibility:
Criteria:
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;
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhao
Facility:
Name:
Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Li
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Wu Zhuang
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang
Facility:
Name:
Sun Yatsen University Cancer Center Huangpu Hos
Address:
City:
Guangzhou
Zip:
510700
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang
Facility:
Name:
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qitao Yu
Contact backup:
Last name:
Cuiyun Su
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Yu
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingya Li
Facility:
Name:
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
45008
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiming Wang
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaorong Dong
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junhong Zhang
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Yang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongchang Zhang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wang
Contact backup:
Last name:
Bolin Chen
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Longhua Sun
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhentian Liu
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jiuwei Cui
Facility:
Name:
The First Hospital of Chinese Medical University(Heping Compus)
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiujuan Qu
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Yao
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiyong Wang
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Baohui Han
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengfei Zhu
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Recruiting
Contact:
Last name:
Junli Xue
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
30009
Country:
China
Status:
Recruiting
Contact:
Last name:
Xia Song
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenxiu Yao
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongsheng Wang
Facility:
Name:
Chengdu Fifth People's Hospital
Address:
City:
Chengdu
Zip:
611130
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lang He
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Chen
Facility:
Name:
Yunnan Cancer Hospital,The Third Affiliated Hospital of Kunming Medical University ,Yunnan Cancer Center
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunchao Huang
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianya Zhou
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yun Fan
Facility:
Name:
High Technology Hospital MedCenter LTD
Address:
City:
Batumi
Zip:
6000
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Tamta Makharadze
Facility:
Name:
ISR-GEO Med Res Clin Healthycore
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Ekaterine Arkania
Facility:
Name:
LLC "Todua Clinic"
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Tamar Melkadze
Facility:
Name:
Ltd New Hospitals
Address:
City:
Tbilisi
Zip:
0114
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Davit Giorgadze
Facility:
Name:
Tbilisi St Med U Ingorokva High Med
Address:
City:
Tbilisi
Zip:
0144
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Miranda Gogishvili
Facility:
Name:
LTD Institute of Clinical Oncology
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Vladimer Kuchava
Facility:
Name:
LTD "Multiprofile Clinic Consilium Medulla"
Address:
City:
Tbilisi
Zip:
0186
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Tsira Kortua
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Ilhwan Kim
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Ki Hyeong Lee
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-Si
Zip:
13620
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Se Hyun Kim
Facility:
Name:
The Catholic University of Korea, St. Vincent's Hospital
Address:
City:
Suwon-Si
Zip:
16247
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Byoung Yong Shim
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Byoung Chul Cho
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
6351
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Myung Ju Ahn
Facility:
Name:
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Alina Simona MUNTEAN
Facility:
Name:
Medisprof
Address:
City:
Cluj-Napoca
Zip:
400641
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Anghel Adrian UDREA
Facility:
Name:
Centrul de Oncologie Sf. Nectarie
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Michael Schenker
Facility:
Name:
Ovidius Clinical Hospital
Address:
City:
Constanta
Zip:
905900
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Laura Mazilu
Facility:
Name:
Hospital Universitario Puerta De Hierro De Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Mariano Provencio Pulla
Facility:
Name:
Hospital Universitario QuirónSalud Madrid
Address:
City:
Pozuelo de Alarcón
Zip:
28223
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Belen Rubio Viqueira
Facility:
Name:
Micancer Center S.L.P.
Address:
City:
Barcelona
Zip:
08017
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Santiago Viteri Ramrez
Facility:
Name:
Hospital Universitari Dexeus Grupo Quironsalud
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Andres Aguilar Hernandez
Facility:
Name:
Hospital Universitari Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Enriqueta Felip Font
Facility:
Name:
Hospital Quironsalud Malaga
Address:
City:
Málaga
Zip:
29004
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Manuel Cobo Dols
Facility:
Name:
Hospital Universitario Virgen de Valme
Address:
City:
Sevilla
Zip:
41014
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jose Fuentes Pradera
Facility:
Name:
Hospital Clinico Universitario De Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Paloma Martin Martorell
Facility:
Name:
Medical Park Seyhan Hospital
Address:
City:
Adana
Zip:
01140
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Ahmet Sezer
Facility:
Name:
Adana City Training and Research Hospital
Address:
City:
Adana
Zip:
01370
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Timucin Cil
Facility:
Name:
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Nuri Karadurmus
Facility:
Name:
Hacettepe University Medical Faculty
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mustafa Erman
Facility:
Name:
Gazi University Medical Faculty
Address:
City:
Ankara
Zip:
06500
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Ozan Yazici
Facility:
Name:
Ankara Liv Hospital Tibbi Onkoloji
Address:
City:
Ankara
Zip:
06680
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Saadettin Kilickap
Facility:
Name:
Medical Point Izmir Hospital
Address:
City:
Izmir
Zip:
35575
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Cagatay Arslan
Facility:
Name:
Inonu University Turgut Ozal Medical Center
Address:
City:
Malatya
Zip:
44280
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mustafa Dikilitas
Start date:
April 19, 2023
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Klus Pharma Inc.
Agency class:
Industry
Collaborator:
Agency:
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Klus Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816252
