ZG006 plus PD‑1/PD‑L1 immunotherapy as first‑line treatment for extensive‑stage small cell lung cancer

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

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07231445 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Cong Zhang

Conditions Small Cell Lung Cancer