Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later May 30, 2027 → Dec 30, 2027
See other at-risk trials from Impact Biotech Ltd

Record History

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  1. Primary completion pushed from May 30, 2027 to Dec 30, 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 3 entries
    • Enrollment closed, study ongoing
    • Start date changed from estimate of May 28, 2025 to May 28, 2024
    • Eligibility criteria expanded, about 36 words
    • Site details revised
  2. Start date: Dec 28, 2024 to May 28, 2025v6
  3. Trial status: Suspended to Recruiting
    • Start date: May 30, 2025 to Dec 28, 2024
    • Site details revised
    v5
  4. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Study is on hold by Sponsor
    • Primary completion date: May 30, 2026 to May 30, 2027
    • Start date: May 30, 2024 to May 30, 2025
    • Study completion date: Dec 30, 2027 to Dec 30, 2028
    v4
  5. Primary completion date: Mar 30, 2025 to May 30, 2026
    • Start date: Oct 30, 2023 to May 30, 2024
    • Study completion date: Dec 30, 2026 to Dec 30, 2027
    v3
  6. Lead sponsor: Steba Biotech S.A. to Impact Biotech Ltd
    • Collaborators shortened, about 3 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects. Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Surgery will be performed at 5-21 days following the VTP procedure. Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.
Trial Details
NCT Number NCT05918783
Lead Sponsor Impact Biotech Ltd
Conditions
(from sponsor)		 Peripheral Lung Tumor
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov