A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer(FASTIL-Lung02)

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Oct 2027 → Oct 2028
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Hangzhou Huasai Biomedicine Co., Ltd.

Record History

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  1. Study title revised
  2. Primary and study completion pushed from Oct 2027 to Oct 2028 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: Qingdao Sino-Cell Biomedicine Co., Ltd. to Hangzhou Huasai Biomedicine Co., Ltd.
    • Recruitment opened
    • Enrollment increased: 12 → 24 participants
    • Start date changed from estimate of Oct 2026 to Sep 21, 2026
    • Secondary endpoints expanded, about 8 words
    • Eligibility criteria expanded, about 2 words
  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.
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.
Trial Details
NCT Number NCT07830342
Lead Sponsor Hangzhou Huasai Biomedicine Co., Ltd.
Conditions
(from sponsor)		 Advanced NSCLC
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov