ZG006 versus investigator-selected chemotherapy for relapsed small-cell lung cancer
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
PHASE3 · Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT07189455
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd (industry) |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07189455 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Hewen Yin
- Email: yinhw@zelgen.com
- Phone: +86-0512-57309965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small-cell Lung Cancer