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Набира участници Фаза 3 NCT07218146

A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Small-cell Lung Cancer

Спонсор: Zai Lab (Shanghai) Co., Ltd.

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
Кой може да участва
Inclusion Criteria: * Age \>/= 18 years, or considered an adult by local regulations, at the time of consent * Signed informed consent * Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed. * Measurable disease according to RECIST v1.1 as assessed by the investigator. * Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol. * Adequate organ and marrow function * Eastern Cooperative Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months * Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening * Participants must be willing and able to comply with protocol for the duration of the study Exclusion Criteria: * Received more than one line of systemic therapy for Extensive-Stage SCLC. * Received any prior ADC with topoisomerase 1 inhibitor payload * Participants with another known malignancy with exceptions defined in the protocol. * History or suspected ILD/pneumonitis based on criteria per protocol * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment. * Prior radiotherapy before study treatment based on criteria per protocol * Unresolved toxicity of Grade \>/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. * Known infection or active infection defined in the protocol. * Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.
Интервенции
ZL-1310
DRUG
Investigator's Choice of Therapy
DRUG
Места на провеждане 34
Китай (9)
Zai Lab SIte 01026
Chengdu , Sichuan
Zai Lab Site 01001
Guangzhou , Guangdong
Zai Lab Site 01017
Hangzhou , Zhejiang
Zai Lab Site 01007
Jinan , Shandong
Zai Lab Site 01005
Linyi , Shandong
Zai Lab Site 01015
Nanchang , Jiangxi
Zai Lab Site 01011
Naning , Guangxi
Zai Lab Site 01034
Wuhan , Hubei
Zai Lab Site 01010
Zhengzhou , Henan
Япония (3)
Zai Lab Site 10017
Fukuoka
Zai Lab Site 10013
Osaka
Zai Lab Site 10003
Shimosuga , Tochigi
САЩ (22)
Zai Lab Site 02025
Austin , Texas
Zai Lab Site 02003
Bethesda , Maryland
Zai Lab Site 02035
Broomall , Pennsylvania
Zai Lab Site 02045
Clermont , Florida
Zai Lab Site 02024
Cleveland , Ohio
Zai Lab Site 02023
Columbia , Missouri
Zai Lab Site 02006
Fairfax , Virginia
Zai Lab Site 02041
Louisville , Kentucky
Zai Lab Site 02019
Media , Pennsylvania
Zai Lab Site 02036
Nashville , Tennessee
Zai Lab Site 02030
New Haven , Connecticut
Zai Lab Site 02025
Odessa , Texas
Zai Lab Site 02031
Orange City , Florida
Zai Lab Site 02021
Peoria , Illinois
Zai Lab Site 02049
Peoria , Illinois
Zai Lab Site 02008
Pittsburgh , Pennsylvania
Zai Lab Site 02029
Pittsburgh , Pennsylvania
Zai Lab Site 02020
Rockledge , Florida
Zai Lab Site 02026
Sarasota , Florida
Zai Lab Site 02022
Silver Spring , Maryland
Zai Lab Site 02009
St Louis , Missouri
Zai Lab Site 02040
The Bronx , New York
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
30.11.2025
Крайна дата
30.11.2028
Регистрационен номер
NCT07218146
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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