Neuroendocrine Carcinomas (NEC)Phase 3NCT07833839
ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
A Phase 3 study testing ZG005 for Injection, Etoposide Injection and Cisplatin Injection in people with Neuroendocrine Carcinomas (NEC), run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants with advanced NEC who are naive to systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroendocrine Carcinomas (NEC)
- What is being tested?
- ZG005 for Injection, Etoposide Injection and Cisplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Dec 2031
- 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
- Participant has fully understood the trial, agrees to comply with the study treatment regimen and visit schedule, and voluntarily signs the informed consent form (ICF).
- Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
- Life expectancy of more than 3 months.
- Histologically confirmed recurrent or metastatic neuroendocrine carcinoma (NEC).
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
Who cannot join
- History, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of central nervous system (CNS) metastases or leptomeningeal metastases.
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, 450052
Lijie Song, 13939020459, lijiesongcn@hotmail.com
About this study
Official title: A Randomized, Double-Blind, Controlled, Multicenter Phase III Clinical Trial of ZG005 in Combination With Etoposide and Cisplatin Versus Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
This is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants with advanced NEC who are naive to systemic therapy.
- Conditions
- Neuroendocrine Carcinomas (NEC)
- Being tested
- ZG005 for Injection, Etoposide Injection, Cisplatin Injection, ZG005 placebo for injection
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG005 for InjectionDrug
Intravenous infusion
Etoposide InjectionDrug
Intravenous infusion
Cisplatin InjectionDrug
Intravenous infusion
ZG005 placebo for injectionDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ZG005 + Etoposide + Cisplatin | Experimental | Treatment arm Receives: Drug: ZG005 for Injection; Drug: Etoposide Injection; Drug: Cisplatin Injection |
| ZG005 Placebo + Etoposide + Cisplatin | Active comparator | Control arm Receives: Drug: Etoposide Injection; Drug: Cisplatin Injection; Drug: ZG005 placebo for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Up to 48 months
Secondary outcomes (4)
Progression-free survival (PFS)
Measured: Up to 48 months
Objective Response Rate (ORR)
Measured: Up to 48 months
Duration of response (DoR)
Measured: Up to 48 months
Occurrence of adverse event (AE) and serious adverse event (SAE)
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Carcinomas (NEC)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833839
- Sponsor's protocol ID
- ZG005-010
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled, Multicenter Phase III Clinical Trial of ZG005 in Combination With Etoposide and Cisplatin Versus Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07833839
- Acronym / sponsor ID
- ZG005-010
- Conditions
- Neuroendocrine Carcinomas (NEC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 22 Sep 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 is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants with advanced NEC who are naive to systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZG005 + Etoposide + Cisplatin | Experimental | Drug: ZG005 for Injection, Drug: Etoposide Injection, Drug: Cisplatin InjectionTreatment arm |
| ZG005 Placebo + Etoposide + Cisplatin | Active comparator | Drug: Etoposide Injection, Drug: Cisplatin Injection, Drug: ZG005 placebo for injectionControl arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has fully understood the trial, agrees to comply with the study treatment regimen and visit schedule, and voluntarily signs the informed consent form (ICF).
- Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
- Life expectancy of more than 3 months.
- Histologically confirmed recurrent or metastatic neuroendocrine carcinoma (NEC).
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
Key exclusion criteria (1 listed)
- History, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of central nervous system (CNS) metastases or leptomeningeal metastases.
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 |
|---|---|---|
| ZG005 for InjectionIntravenous infusion | Drug | ZG005 + Etoposide + Cisplatin |
| Etoposide InjectionIntravenous infusion | Drug | ZG005 + Etoposide + Cisplatin, ZG005 Placebo + Etoposide + Cisplatin |
| Cisplatin InjectionIntravenous infusion | Drug | ZG005 + Etoposide + Cisplatin, ZG005 Placebo + Etoposide + Cisplatin |
| ZG005 placebo for injectionIntravenous infusion | Drug | ZG005 Placebo + Etoposide + Cisplatin |
Primary outcome
Overall survival (OS)
Time frame: Up to 48 months
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 48 months
Objective Response Rate (ORR)
Time frame: Up to 48 months
Duration of response (DoR)
Time frame: Up to 48 months
Occurrence of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to 48 months
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 22 Sep 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.
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 ZG005 for Injection, Etoposide Injection and Cisplatin Injection in people with Neuroendocrine Carcinomas (NEC), 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: opening soon, as of the sponsor's last update on 22 Sep 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 48 months). 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 22 Sep 2026.