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Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

ConditionSmall-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZG006

    Drug

    ZG006 will be administered as an intravenous (IV) infusion.

  • Topotecan

    Drug

    Topotecan will be administered per local standard of care

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: ZG006Experimental treatment 1 intervention
Group B: Investigator-Selected ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 3 years

Secondary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to approximately 3 years
2

Serum Concentrations of ZG006

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
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