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RecruitingNCT07189455Updated Jan 5, 2026

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

A Phase 3 interventional study of ZG006 and Topotecan in Small-cell Lung Cancer, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Small-cell Lung Cancer
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 340 are open to participants now.

This study's planned enrollment of 420 is above the median of 56 across 1,030 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Participants were deemed unsuitable for participating in the study by the investigator for any reason.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    ZG006

    ZG006 10 mg Q2W

    Drug: ZG006

  • Active comparator
    Investigator-Selected Chemotherapy

    Investigator-selected chemotherapy, such as topotecan.

    Drug: Topotecan

Interventions

  • DrugZG006

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

  • DrugTopotecan

    Topotecan will be administered per local standard of care

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 3 years

  2. Serum Concentrations of ZG006

    Time frame: Up to approximately 3 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality 200030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07189455
Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Dec 12, 2025
Primary completion
Oct 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 5, 2026

Study contacts

Hewen Yin
Contact
yinhw@zelgen.com
+86-0512-57309965
Jason Wu
study chair · Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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