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

Study acronym: DLLEVATE
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Notable Primary endpoints: details revised at 2 of 2 entries Show 4 more changesShow less
    • Trial sites expanded: 155 → 165 locations
    • Interventions: Investigator's Choice of Therapy (Drug), ZL-1310 (Drug) to Investigator's Choice of Therapy (Drug), ZL-1310 (Drug)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 9 of 9 entries
  2. Minor Re-verified, no change to tracked fieldsv12
  3. Minor Trial sites expanded: 111 → 155 locationsv11
  4. Minor Trial sites expanded: 76 → 111 locations
    • Secondary endpoints: details revised at 9 of 9 entries
    v10
  5. Minor Trial sites expanded: 66 → 76 locations
    • Site details revised at 5 of 76 sites
    v9
  6. Minor Study sites: 66 to 76v8
  7. Minor Trial sites expanded: 56 → 66 locationsv7
  8. Minor Trial sites expanded: 34 → 56 locationsv6
  9. Minor Trial sites expanded: 14 → 34 locationsv5
  10. Minor Study sites: 9 to 14v4
  11. Minor Study sites: 5 to 9
    • Study title expanded, about 1 word
    v3
  12. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Enrollment target: 665 to 480
    • Study sites: 0 to 5
    • Primary completion date: Nov 30, 2028 to Jun 30, 2028
    • Study completion date: May 31, 2029 to Nov 30, 2028
    • Interventions: Investigator's Choice of Therapy (Drug), ZL-1310 Dose Level 1 (Drug), ZL-1310 Dose Level 2 (Drug) to Investigator's Choice of Therapy (Drug), ZL-1310 (Drug)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study arms: 3 to 2
  13. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07218146
Lead Sponsor Zai Lab (Shanghai) Co., Ltd.
Collaborators: Zai Lab (US) LLC
Conditions
(from sponsor)
Small-cell Lung Cancer
Related terms Small Cell Lung Carcinoma
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov