A Study of ZL-1310 in Subjects With Small Cell Lung Cancer

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 8 entries
    • Trial sites expanded: 38 → 41 locations
    • Eligibility criteria expanded, about 25 words
  2. Study sites revised (38)v13
  3. Re-verified, no change to tracked fieldsv12
  4. Enrollment target: 112 to 339
    • Eligibility criteria expanded, about 37 words
    • Study arms: 10 to 13
    v11
  5. Site details revised at 6 of 38 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary endpoints: 9 to 8v9 Show 4 more changesShow less
    • Study sites: 33 to 38
    • Eligibility criteria expanded, about 112 words
    • Secondary endpoints: 21 to 7
    • Study arms: 6 to 10
  2. Study sites: 20 to 33v8
  3. Primary endpoints: 6 to 9v7 Show 8 more changesShow less
    • Study sites: 14 to 20
    • Primary completion date: Jul 30, 2027 to May 30, 2027
    • Study completion date: Dec 31, 2027 to Jul 31, 2027
    • Interventions: Atezolizumab (Drug), ZL-1310 (Drug) to Atezolizumab (Drug), Carboplatin (Drug), ZL-1310 (Drug)
    • Eligibility criteria expanded, about 143 words
    • Secondary endpoints: 14 to 21
    • Study arms: 4 to 6
    • Study description shortened, about 5 words
  4. Primary endpoints: 3 to 6v6 Show 8 more changesShow less
    • Enrollment target: 85 to 112
    • Interventions: ZL-1310 (Drug) to Atezolizumab (Drug), ZL-1310 (Drug)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 7 to 14
    • Site details revised at 3 of 14 sites
    • Study arms: 3 to 4
    • Study description expanded, about 2 words
    • Study title shortened, about 2 words
  5. Enrollment target: 140 to 85
    • Study sites: 10 to 14
    v5
  6. Site details revised at 2 of 10 sitesv4
  7. Eligibility criteria shortened, about 42 words
    • Secondary endpoints: 11 to 7
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2024 to Jan 23, 2024
    • Site details revised at 10 of 10 sites
    v2
  1. 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.
An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer
Trial Details
NCT Number NCT06179069
Lead Sponsor Zai Lab (Shanghai) Co., Ltd.
Collaborators: Zai Lab (US) LLC
Conditions
(from sponsor)		 SCLC
Enrollment 339 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov