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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Small-cell Lung Cancer

Treatments: Drug: Topotecan; Drug: ZG006

Study type: Interventional

Funder types: Industry

Identifiers

NCT07189455

ZG006-006

Details and patient eligibility

About

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

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

ZG006

Experimental group

Description:

ZG006 10 mg Q2W

Treatment:

Drug: ZG006

Investigator-Selected Chemotherapy

Active Comparator group

Description:

Investigator-selected chemotherapy, such as topotecan.

Treatment:

Drug: Topotecan