Clinical Trial

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer

MOA: ZL-1310 is an ADC that targets DLL3 and contains a topoisomerase I inhibitor payload

Key Eligibility Criteria:

• Confirmed diagnosis of SCLC
• Archival tumor tissue or fresh tumor tissue must be submitted at screening. DLL3 expression will be assessed retrospectively (fine needle aspiration biopsies are not sufficient)
  • NOTE: if archived tissue is not available/insufficient and a biopsy is not feasible, the patient may still be enrolled with Sponsor’s approval
• Must have received only 1L plt-based chemo and had documented disease progression during/after most recent systemic tx
  • Prior 1L systemic tx should be plt-base chemo with an anti-PD(L)1 agent
    • Maintenance tx with anti-PD-(L1)/lurbinectedin/tarlatamab does not count as a separate line of tx
    • Plt-based chemo for limited-stage SCLC is considered one line of tx if disease progression occurs within 6 months of completion of plt-based chemo
  • 2L systemic tx is not allowed, except for tarlatamab
• Measurable disease according to RECIST v1.1
• Prior tx with ADC containing any topoisomerase I inhibitor payload are excluded
• Treated and stable CNS metastases are eligible (parenchimal).
  • Metastasis to leptomeninges are excluded
• Untreated and asymptomatic CNS metastases are eligible but must not require steroids and/or anti-convulsants, nor local tx