ZG006 plus PD‑1/PD‑L1 immunotherapy as first‑line treatment for extensive‑stage small cell lung cancer
Official title: A Phase Ib Study Evaluating the Safety and Efficacy 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
Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT07231445 · Data updated 2026-11-12
This study will test whether adding ZG006 to PD‑1/PD‑L1 immunotherapy (with or without chemotherapy) is safe and improves outcomes for people with extensive‑stage small cell lung cancer starting first‑line treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 21, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07231445 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18–75) with histologically confirmed extensive‑stage SCLC, ECOG 0–1, no prior systemic therapy for extensive‑stage disease, life expectancy ≥3 months, and willingness to consent and comply with study visits.
✕Probably not a fit
Patients with poor performance status (ECOG ≥2), significant uncontrolled comorbidities, prior systemic treatment for extensive‑stage disease, or those judged unsuitable by the investigator are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, multicenter phase 1b trial combines the experimental agent ZG006 with PD‑1/PD‑L1 immune checkpoint inhibitors (including serplulimab) with or without chemotherapy as first‑line therapy for extensive‑stage small cell lung cancer. It enrolls adults aged 18–75 with histologically or cytologically confirmed ES‑SCLC, ECOG performance status 0–1, and life expectancy of at least 3 months. The primary focus is on safety and tolerability, with exploratory efficacy endpoints such as response rate and progression‑free survival. Participants are randomized to receive the combination regimen and undergo scheduled clinical assessments and imaging per protocol.
Why it matters
Potential benefit: If successful, this combination could increase response rates and extend survival compared with current first‑line options.
How similar studies have gone: Adding PD‑1/PD‑L1 inhibitors to chemotherapy has improved outcomes in prior trials for extensive‑stage SCLC, but combining those agents with the novel drug ZG006 is experimental and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Cong Zhang
- Email: zhangc@zelgen.com
- Phone: 17602176888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.