Neuroendocrine CarcinomaPhase 3NCT07595913
A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
A Phase 3 study testing ZG006 and 5-fluorouracil, Calcium folinate and Irinotecan in people with Neuroendocrine Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroendocrine Carcinoma
- What is being tested?
- ZG006 and 5-fluorouracil, Calcium folinate and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to 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
- Has provided written informed consent voluntarily after being fully informed about the study.
- Male or female, aged 18 to 75 years (inclusive) at the time of informed consent signing.
- Histologically or cytologically confirmed advanced neuroendocrine carcinoma (NEC); small cell lung cancer (SCLC) and combined SCLC are excluded. Additionally, the Participants with DLL3-positive NEC who have received prior systemic therapy (second-line and above)..
Who cannot join
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.
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
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Lijie Song
About this study
Official title: A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.
- Conditions
- Neuroendocrine Carcinoma
- Being tested
- ZG006, 5-fluorouracil, Calcium folinate and Irinotecan
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG006Biological
ZG006 will be administered as an intravenous (IV) infusion.
5-fluorouracil, Calcium folinate and IrinotecanDrug
Also called FOLFIRI
Irinotecan 180 mg/m^2, Calcium folinate 400 mg/m^2, 5-Fluorouracil: 400 mg/m^2 by intravenous infusion on Day 1; 5-Fluorouracil: 2400 mg/m^2 by continuous intravenous infusion over 46 to 48 hours， once two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | ZG006 Q2W Receives: Biological: ZG006 |
| Control Group | Active comparator | Investigator-selected chemotherapy (such as FOLFIRI regimen) Receives: Drug: 5-fluorouracil, Calcium folinate and Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival（OS）
Duration from the date of initial treatment to the date of death due to any cause.
Measured: up to approximately 4 years
Secondary outcomes (1)
Progression-free Survival (PFS) (RECIST1.1)
A duration from the date of initial treatment to disease progression or death of any cause.
Measured: up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startJul 2026 (estimated)
- Primary completionJun 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 Neuroendocrine CarcinomaStudies 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
- 240 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
- NCT07595913
- Sponsor's protocol ID
- ZG006-009
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07595913
- Acronym / sponsor ID
- ZG006-009
- Conditions
- Neuroendocrine Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 May 2026 (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.
This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: ZG006ZG006 Q2W |
| Control Group | Active comparator | Drug: 5-fluorouracil, Calcium folinate and IrinotecanInvestigator-selected chemotherapy (such as FOLFIRI regimen) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has provided written informed consent voluntarily after being fully informed about the study.
- Male or female, aged 18 to 75 years (inclusive) at the time of informed consent signing.
- Histologically or cytologically confirmed advanced neuroendocrine carcinoma (NEC); small cell lung cancer (SCLC) and combined SCLC are excluded. Additionally, the Participants with DLL3-positive NEC who have received prior systemic therapy (second-line and above)..
Key exclusion criteria (1 listed)
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.
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. | Biological | Test Group |
| 5-fluorouracil, Calcium folinate and IrinotecanAlso: FOLFIRIIrinotecan 180 mg/m^2, Calcium folinate 400 mg/m^2, 5-Fluorouracil: 400 mg/m^2 by intravenous infusion on Day 1; 5-Fluorouracil: 2400 mg/m^2 by continuous intravenous infusion over 46 to 48 hours， once two weeks. | Drug | Control Group |
Primary outcome
Overall Survival（OS）
Time frame: up to approximately 4 years
Duration from the date of initial treatment to the date of death due to any cause.
1 secondary outcome
Progression-free Survival (PFS) (RECIST1.1)
Time frame: up to approximately 4 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 19 May 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 5-fluorouracil, Calcium folinate and Irinotecan in people with Neuroendocrine Carcinoma, 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 3 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: opening soon, as of the sponsor's last update on 19 May 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 Shangdi Ning (+86-0512-57309965, ningsd@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 4 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 19 May 2026.