A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorZai Lab (Shanghai) Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.

Eligibility criteria

Qualifiers

Age >/= 18 years, or considered an adult by local regulations, at the time of consent

Signed informed consent

Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.

Measurable disease according to RECIST v1.1 as assessed by the investigator.

Disqualifiers

Received more than one line of systemic therapy for Extensive-Stage SCLC.

Received any prior ADC with topoisomerase 1 inhibitor payload

Participants with another known malignancy with exceptions defined in the protocol.

History or suspected ILD/pneumonitis based on criteria per protocol

Trial design

Treatments tested in this trial

  • ZL-1310
  • Investigator's Choice of Therapy

Treatment groups

480 Participants
are divided into 2 treatment groups

Locations

66
China
Zai Lab Site 01002230036, HefeiAnhui, China
Zai Lab Site 01014361000, XiamenFujian, China
Zai Lab Site 01001510080, GuangzhouGuangdong, China
Zai Lab Site 01011530021, NaningGuangxi, China

Sponsors and collaborators

Zai Lab (Shanghai) Co., Ltd.

Lead sponsor

Zai Lab (US) LLC

Collaborator