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

Sponsor: Zai Lab (Shanghai) Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT07218146

This study assesses the efficacy and safety of ZL-1310 versus Investigator's Choice Therapy in relapsed SCLC patients. Eligible participants are adults with confirmed SCLC, measurable disease, and adequate organ function. Interventions include ZL-1310 or therapies like Topotecan, Lurbinectedin, or Amrubicin. Participants must comply with study protocols and provide tumor samples.

Patient Parameters

Program Overview

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

Inclusion Criteria

  • 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.
  • Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
  • Adequate organ and marrow function
  • Eastern Cooperative Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
  • Participants must be willing and able to comply with protocol for the duration of the study

Exclusion Criteria

  • 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
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
  • Prior radiotherapy before study treatment based on criteria per protocol
  • Unresolved toxicity of Grade >/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
  • Known infection or active infection defined in the protocol.
  • Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.

Locations

FACILITYZIPCITYSTATE
Zai Lab Site 0204534711ClermontFlorida
Zai Lab Site 0203132763Orange CityFlorida
Zai Lab Site 0202634232SarasotaFlorida
Zai Lab Site 0201961615PeoriaIllinois
Zai Lab Site 0204961637PeoriaIllinois
Zai Lab Site 0204140202LouisvilleKentucky
Zai Lab Site 0200320817BethesdaMaryland
Zai Lab Site 0202365201ColumbiaMissouri
Zai Lab Site 0201919063MediaPennsylvania

Get This Program In Your Inbox

You can sign up and apply your patients for this program.