Clinical trial · Interventional
A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma
NCT07595913CI-TRIAL-00111980not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil, Calcium folinate and Irinotecan | Drug | — | UNRESOLVED |
| ZG006 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Group
- description
- ZG006 Q2W
- interventionNames
- Biological: ZG006
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Investigator-selected chemotherapy (such as FOLFIRI regimen)
- interventionNames
- Drug: 5-fluorouracil, Calcium folinate and Irinotecan
Primary outcomes (1)
- measure
- Overall Survival（OS）
- timeFrame
- up to approximately 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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).. Exclusion Criteria: * Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.