Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

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.

More Small Cell Lung Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment420 (estimated)
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Industry-sponsored
Drugs / interventionsChemotherapy
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedDecember 12, 2025
Main results expectedOctober 2028
Study endsDecember 2028
Registry record updatedJanuary 5, 2026
Trial IDNCT07189455 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.