Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

Phase 3RecruitingNCT07189455

Suzhou Zelgen Biopharmaceuticals Co.,Ltd420 enrolled

Overview

The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

Small-cell Lung Cancer

Interventions

ZG006DRUG

ZG006 will be administered as an intravenous (IV) infusion.

TopotecanDRUG

Topotecan will be administered per local standard of care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form; * Male or female 18\~75 years of age; * Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; * Life expectancy ≥ 3 months; * Histologically or cytologically confirmed Small Cell Lung Cancer. Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Overall Survival (OS)

Time frame: Up to approximately 3 years

Secondary Outcomes

Number of participants with adverse events (AEs)

Time frame: Up to approximately 3 years

Serum Concentrations of ZG006

Time frame: Up to approximately 3 years

Central Contacts

Hewen Yin

CONTACT

+86-0512-57309965 yinhw@zelgen.com

Data from ClinicalTrials.gov

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