A trial to evaluate whether the combination encorafenib and binimetinib is safe and effective in Chinese participants with BRAFV600E lung cancer

 

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Multicenter, Open-label, Phase II Study with a Safety Lead-in part Investigating the Efficacy, Safety and Pharmacokinetics of Encorafenib and Binimetinib Combination in BRAFV600E mutated Chinese Patients with Metastatic Non-Small Cell Lung Cancer who are BRAF- and MEK inhibitor treatment-naïve

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Status
Status :
Recruiting
Type of study
Phase II
Min. Age
18
Years old
Max. Age
-
Gender
All

Brief summary

At the time of the initiation of the OCEAN II trial, there was no therapy available in China for the treatment of patients with lung cancer targeting the specific genetic mutation called BRAFV600E mutation.

The combination of encorafenib and binimetinib is a marketed therapy (Braftovi® and Mektovi®) approved to treat patients with certain skin cancer (melanoma) in several countries (European Union, USA, Australia, Japan, Switzeland...).

Data of previous clinical studies have shown that the same type (BRAF and MEK inhibitors) is effective for lung cancer.

This trial is a two-part trial to evaluate whether the combination of encorafenib and binimetinib is safe and effective in a specific group of metastatic BRAFV600E mutated lung cancer (non-small cell lung cancer) in Chinese participants.

Therapeutic area :
Oncology
Disease :
Metastatic non-small cell lung cancer
Study medication :
Encorafenib (BRAFTOVI®) - Binimetinib (MEKTOVI®)
Phase : Phase II
Start Date :
02 June 2022
End Date / Planned study Completion Date :
February 2025
Study ID : W00090GE203
CT.gov Number : NCT05195632
Countries :
China
Taiwan

Find out where the clinical trial is conducted

1

Zhejiang Cancer Hospital

38 Guangji Road Banshan Bridge Gongshu District
Hangzhou zhejiang
310022
China

2

Xiangya Hospital Central South University

87 Xiangya Road
Changsha hunan
410013
China

3

Union Hospital Tongji medical college Huazhong

University of Science and Technology 1277 Jiefang Avenue
Wuhan hubei
430022
China

4

Tongji Medical College of HUST

No.1095 Jiefang Avenue
Wuhan hubei
430030
China

5

Tianjin Medical University Cancer Institute and Hospital

99 Dongwu Road Konggang Economic Zone Dongli District
Tianjin
300060
China

6

The Second Hospital of Dalian University

467 Zhongshan Road
Dalian liaoning
116023
China

7

The Northern Jiangsu People's Hospital

98 Nantongxilu
Yangzhou jiangsu
225007
China

8

The Fourth Hospital of Hebei Medical University

12 Jiankang Road
Shijiazhuang hebei
212050
China

9

The First hospital of Jilin University

NO. 71 Xinmin Main Street
Changchun jilin
130021
China

10

The First Hospital of China Medical University

No 155 Nanjingbeijie
Shenyang liaoning
110001
China

11

The First Affiliated Hospital of Nanchang University

17 Yongwaizheng St.
Nanchang jiangxi
330209
China

12

The First Affiliated Hospital of Jinzhou Medical University

No.2, Section 5, Renmin Street, Guta District
Jinzhou city liaoning
121012
China

13

Sir Run Run Shaw Hospital Zhejiang

University School of Medicine 3 East Qingchun Road
Hangzhou zhejiang
310016
China

14

Shanxi Cancer Hospital

No 3 Zhigongxinjie
Taiyuan shanxi
030013
China

15

Shandong Cancer Hospital

440 Jiyan Road
Jinan shangdong
250117
China

16

Peking University Shenzhen Hospital

1120 Lianhualu
Shenzhen guangdong
518036
China

17

Peking University First Hospital

No. 8, Xishiku Street
Beijing
100034
China

18

Liaoning Cancer Hospital

44 Xiaoheyanlu
Shenyan liaoning
110042
China

19

Henan Cancer Hospital

127 Dongming Road
Zhengzhou henan
450003
China

20

Harbin Medical University Cancer Hospital

Haping Road No.150
Harbin heilongjiang
150040
China

21

Hainan General Hospital

19 Xiuhualu
Haikou hainan
570311
China

22

Guangxi Medical University Affiliated Tumor Hospital

71 Hedi Road, Qingxiu District Nanning
Guangxi
530021
China

23

Guangdong Provincial People’s Hospital

No. 106 Zhongshan Er Rd.
Guangzhou guangdong
510317
China

24

Fuzhou Pulmonary Hospital of Fujian

2 Hubian Rd, Cangshan District
Fuzhou fujian
350008
China

25

Fujian Medical University Union Hospital

29 Xinquanlu
Fuzhou fujian
350001
China

26

First Affiliated Hospital, Zhejiang

University School of Medicine 79 Qingchunlu
Hangzhou zhejiang
310058
China

27

Taipei Veterans General Hospital

No.201, Sec. 2, Shipai Rd. Beitou District
Taipei city, 11217
Taiwan

28

National Taiwan University Hospital

No. 7 Zhongshan S. Rd Zhongzheng Dist
Taipei city, 100
Taiwan

29

Yantai Yuhuangding Hospital

20 Yuhuangding East Road
Yantai
264008
China

30

Sun Yan-Sen University Cancer Center-Huangpu Branch

Exit D, Hetangxia Subway Station Zhongxin Knowledge City Huangpu District
Guangzhou guangdong
510070
China

31

Sun Yan-Sen University Cancer Center

651 East Dongfeng Lu
Guangzhou guangdong
510060
China

32

Sichuan Cancer Hospital

55 Renmin South Road
Chengdu sichuan
610041
China

33

Linyi Cancer Hospital

Intersection of Zhicheng Road and Zhongsheng Street Hedong District
Linyi
276034
China

34

Chongqing Cancer Hospital

No.181 Hanyu Road Shapingba District
Chongqing
400030
China

35

Beijing Cancer Hospital

52 Fuchenglu
Beijing
100142
China

36

Beijing Chest Hospital, Capital Medical University

Yard 9, Beiguan Street Tongzhou District
Beijing
101149
China

Last update at : 09 September 2024

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