HS-IT101 Injection for Advanced NSCLC(FASTIL-Lung01)

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 30, 2026 → Aug 30, 2027
See other at-risk trials from Hangzhou Huasai Biomedicine Co., Ltd.

Record History

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  1. Primary completion pushed from Aug 30, 2026 to Aug 30, 2027 Show 8 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Aug 30, 2025 to Aug 30, 2026
    • Lead sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. to Hangzhou Huasai Biomedicine Co., Ltd.
    • Study completion pushed from Aug 30, 2027 to Aug 30, 2028
    • Interventions modified
    • Eligibility criteria expanded, about 136 words
    • Site details revised
    • Study title revised
  2. Study sites: 0 to 1
    • Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), IL-2 (interleukin 2) (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), HS-IT101 monotherapy (Drug), IL-2 (interleukin 2) (Drug)
    • Eligibility criteria shortened, about 36 words
    v2
  3. 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, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.
Trial Details
NCT Number NCT07105176
Lead Sponsor Hangzhou Huasai Biomedicine Co., Ltd.
Conditions
(from sponsor)		 Advanced Non-Small Cell Lung Cancer
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov