NCT07231445 Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
| NCT ID | NCT07231445 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-04-21 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: * Participants with histologically or cytologically confirmed ES-SCLC. * 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; Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Contact & Investigator
Jason Wu
STUDY CHAIR
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Frequently Asked Questions
Who can join the NCT07231445 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07231445 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07231445 currently recruiting?
Yes, NCT07231445 is actively recruiting participants. Contact the research team at zhangc@zelgen.com for enrollment information.
Where is the NCT07231445 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07231445 clinical trial?
NCT07231445 is sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The principal investigator is Jason Wu at Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The trial plans to enroll 100 participants.
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