NCT07189455

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
31mo left

Started Dec 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

September 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 12, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

September 16, 2025

Last Update Submit

December 30, 2025

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Up to approximately 3 years

Secondary Outcomes (2)

  • Number of participants with adverse events (AEs)

    Up to approximately 3 years

  • Serum Concentrations of ZG006

    Up to approximately 3 years

Study Arms (2)

ZG006

EXPERIMENTAL

ZG006 10 mg Q2W

Drug: ZG006

Investigator-Selected Chemotherapy

ACTIVE COMPARATOR

Investigator-selected chemotherapy, such as topotecan.

Drug: Topotecan

Interventions

ZG006DRUG

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

ZG006
TopotecanDRUG

Topotecan will be administered per local standard of care

Investigator-Selected Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Central Study Contacts

Hewen Yin

CONTACT

+86-0512-57309965yinhw@zelgen.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 24, 2025

Study Start

December 12, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

CN(1)