ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma

Phase 2RecruitingNCT07038096

Suzhou Zelgen Biopharmaceuticals Co.,Ltd350 enrolled

Overview

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

350

Conditions

Small Cell Lung Cancer Neuroendocrine Carcinoma

Interventions

ZG006DRUG

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

ZG005DRUG

ZG005 will be administered as an intravenous (IV) infusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-70 years of age. * Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology. * Eastern Cooperative Oncology Group (ECOG) 0 to 1. * Life expectancy \> 3 months. Exclusion Criteria: * The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Locations (1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Number of Participants Who Experienced Dose-limiting Toxicity (DLT)

Time frame: up to 28 days

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to 2 years

Objective Response Rate (ORR)

The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.

Time frame: Up to 2 years

Secondary Outcomes

Duration of Response (DOR)

Time frame: Up to 2 years

Disease Control Rate (DCR)

Time frame: Up to 2 years

Progression-free Survival (PFS)

Time frame: Up to 2 years

Overall Survival (OS)

Time frame: Up to 2 years

Central Contacts

Hewen Yin

CONTACT

+86-0512-57309965 yinhw@zelgen.com

Data from ClinicalTrials.gov

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