ZG006 versus investigator-selected chemotherapy for relapsed small-cell lung cancer
Official title: A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT07189455 · Data updated 2026-11-12
This trial tests whether ZG006 helps people with relapsed small-cell lung cancer live longer than the chemotherapy their doctor would choose.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | December 12, 2025 |
| Main results expected | October 2028 |
| Study ends | December 2028 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT07189455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with histologically or cytologically confirmed relapsed small-cell lung cancer, ECOG performance status 0–1, and a life expectancy of at least three months are ideal candidates.
✕Probably not a fit
Patients with poorer performance status (ECOG >1), life expectancy under three months, or those judged unsuitable by the investigator are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 interventional trial comparing the investigational agent ZG006 with investigator-selected chemotherapy (for example, topotecan) in participants with relapsed small-cell lung cancer. Participants who meet eligibility criteria will receive either ZG006 or the chosen chemotherapy and be followed for survival and safety outcomes. The main goal is to see if ZG006 prolongs overall survival compared with standard chemotherapy options. The trial enrolls adults with confirmed small-cell lung cancer, good performance status (ECOG 0–1), and a life expectancy of at least three months.
Why it matters
Potential benefit: If successful, ZG006 could extend overall survival compared with current chemotherapy options for relapsed small-cell lung cancer.
How similar studies have gone: Comparisons of new agents versus standard chemotherapy in relapsed small-cell lung cancer have been performed before, but few novel drugs have produced large survival gains in this setting to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; * Histologically or cytologically confirmed Small Cell Lung Cancer. 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: Hewen Yin
- Email: yinhw@zelgen.com
- Phone: +86-0512-57309965
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cirtuvivint plus irinotecan for relapsed small-cell lung cancer
This trial will test whether adding cirtuvivint to irinotecan helps people with relapsed small-cell lung cancer respond better and live longer.
-
Tarlatamab in strong-performance-status small-cell lung cancer
This trial tests whether tarlatamab can help people with extensive-stage small-cell lung cancer and poor health (ECOG 2) who have already had prior treatment.
-
Armored DLL3-SAVVYZ-IL18 CAR T cells for DLL3+ cancers
Aims to see if DLL3-SAVVYZ-IL18 CAR T cells can be safely given to people with DLL3-positive cancers, including certain small cell lung cancers and other neuroendocrine tumors.
-
Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy
This trial tests whether subcutaneous tarlatamab works as well as the IV form for people with extensive-stage small cell lung cancer after platinum chemotherapy.
-
NK Cells Plus Immunotherapy for Extensive-Stage Small Cell Lung Cancer Maintenance
This study tests whether adding allogeneic NK cell therapy to standard immunotherapy helps people with extensive-stage small cell lung cancer who have disease control after initial chemotherapy and immunotherapy.
-
BL-M14D1 plus atezolizumab vs standard therapy in first-line extensive-stage small cell lung cancer
A first-line treatment for adults with extensive-stage small cell lung cancer tests whether adding BL-M14D1 to atezolizumab and standard chemotherapy helps more than standard care.
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.