An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Subject has voluntarily agreed to participate by giving written informed consent for the trial,and Consent to follow trial treatment and visit schedule

• aged 18-75 years (including borderline values) at the time of signing the informed consent form

• Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

• Have a life expectancy of at least 12 weeks

• Subject has at least one measurable target lesion by RECIST 1.1 criteria

• Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing GoBroad Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Guangdong Pharmaceutical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Cancer Hospital
RECRUITING
Hefei
Anhui Provincial Hospital
RECRUITING
Hefei
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Cancer Hospital
RECRUITING
Shenyang
Shanxi Cancer hospital
RECRUITING
Taiyuan
Hubei Cancer Hospital
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
xue kong
kongxue@leadsbiolabs.com
025-83378099
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2027-07-20
Participants
Target number of participants: 178
Treatments
Experimental: LBL-024+Etoposide+Carboplatin/Cisplatin
LBL-024+Etoposide+Carboplatin/Cisplatin Injection,dose A、dose B or dose C; Q3W
Experimental: Atezolizumab+Etoposide+Carboplatin
Atezolizumab+Etoposide+Carboplatin Injection,dose A ; Q3W
Related Therapeutic Areas
Sponsors
Leads: Nanjing Leads Biolabs Co.,Ltd

This content was sourced from clinicaltrials.gov

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