Small-cell Lung CancerPhase 3NCT07189455
Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
A Phase 3 study testing ZG006 and Topotecan in people with Small-cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- ZG006 and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
- Conditions
- Small-cell Lung Cancer
- Being tested
- ZG006, Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG006Drug
ZG006 will be administered as an intravenous (IV) infusion.
TopotecanDrug
Topotecan will be administered per local standard of care
| Study group | Role | What they receive |
|---|---|---|
| ZG006 | Experimental | ZG006 10 mg Q2W Receives: Drug: ZG006 |
| Investigator-Selected Chemotherapy | Active comparator | Investigator-selected chemotherapy, such as topotecan. Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to approximately 3 years
Secondary outcomes (2)
Number of participants with adverse events (AEs)
Measured: Up to approximately 3 years
Serum Concentrations of ZG006
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start12 Dec 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189455
- Sponsor's protocol ID
- ZG006-006
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07189455
- Acronym / sponsor ID
- ZG006-006
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZG006 | Experimental | Drug: ZG006ZG006 10 mg Q2W |
| Investigator-Selected Chemotherapy | Active comparator | Drug: TopotecanInvestigator-selected chemotherapy, such as topotecan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZG006ZG006 will be administered as an intravenous (IV) infusion. | Drug | ZG006 |
| TopotecanTopotecan will be administered per local standard of care | Drug | Investigator-Selected Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: Up to approximately 3 years
2 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately 3 years
Serum Concentrations of ZG006
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZG006 and Topotecan in people with Small-cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hewen Yin (+86-0512-57309965, yinhw@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.