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A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 1, 2025 to Jun 30, 2026 Study sites: 60 to 50 · Completion date: Oct 30, 2026 to Dec 30, 2026v10 Show 2 more changesShow less
    • Study sites: 60 to 50
    • Completion date: Oct 30, 2026 to Dec 30, 2026
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 498 to confirmed 356 · Study sites: 61 to 60v9 Show 2 more changesShow less
    • Enrollment target: estimated 498 to confirmed 356
    • Study sites: 61 to 60
  3. Study sites: 65 to 61 Study title expanded, about 3 wordsv8 Show 1 more changeShow less
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 15 words Study description revised · Site details revised at 30 of 65 sitesv7 Show 2 more changesShow less
    • Study description revised
    • Site details revised at 30 of 65 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 278 to 498 Study sites: 68 to 65 · Completion date: Aug 31, 2026 to Oct 30, 2026 · Study arms: 7 to 8v6 Show 3 more changesShow less
    • Study sites: 68 to 65
    • Completion date: Aug 31, 2026 to Oct 30, 2026
    • Study arms: 7 to 8
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 61 to 68v5
  2. Enrollment target: 296 to 278 Study sites: 14 to 61 · Completion date: Apr 12, 2026 to Aug 31, 2026 · Study arms: 8 to 7v4 Show 3 more changesShow less
    • Study sites: 14 to 61
    • Completion date: Apr 12, 2026 to Aug 31, 2026
    • Study arms: 8 to 7
  3. Study sites: 1 to 14v3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 12, 2023 to Apr 19, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 12, 2023 to Apr 19, 2023
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
Trial Details
NCT Number NCT05816252
Lead Sponsor Klus Pharma Inc.
Collaborators: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 356 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov