Study Comparing ZG006 With Investigator-Selected Chemothe... | NCT07189455

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

NCT07189455

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

420Estimated

Phase

Phase 3

Conditions

Small-cell Lung Cancer

Interventions

ZG006
Topotecan

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2025Actual

Primary Completion Date

Oct 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Sep 16, 2025

First Submission Date that Met QC Criteria

Sep 16, 2025

First Posted Date

Sep 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Jan 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZG006	Experimental	ZG006 10 mg Q2W	Drug: ZG006
Investigator-Selected Chemotherapy	Active Comparator	Investigator-selected chemotherapy, such as topotecan.	Drug: Topotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZG006	Drug	ZG006 will be administered as an intravenous (IV) infusion.	ZG006

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)		Up to approximately 3 years

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (AEs)		Up to approximately 3 years
Serum Concentrations of ZG006		Up to approximately 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hewen Yin	Contact	+86-0512-57309965		yinhw@zelgen.com

Overall Officials

Name	Affiliation	Role
Jason Wu	Suzhou Zelgen Biopharmaceuticals Co.,Ltd	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Chest Hospital	Recruiting	Shanghai	Shanghai Municipality	200030	China

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019772	Topotecan

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided