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Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy

Study acronym: G360-IIT
StatusTerminated
PhasePhase 2
Started
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Record History

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  1. Trial terminated Sponsor's reason: Slow Accrual Show 6 more changesShow less
    • Final enrollment: 5 participants — 5% of the 108 planned
    • Primary completion date changed from estimate of Apr 28, 2027 to Aug 13, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 29 of 30 entries
  2. Re-verified, no change to tracked fieldsv12
  3. Primary and study completion dates: Apr 28, 2026 to Apr 28, 2027v11
  4. 2 versions Re-verified since Jan 12, 2024, no change to tracked fieldsv9-v10
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2023 to Sep 29, 2023
    • Site details revised at 3 of 3 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites revised (3)v7
  2. Start date: Sep 1, 2023 to Oct 1, 2023
    • Primary and study completion dates: Mar 28, 2026 to Apr 28, 2026
    v6
  3. Start date: Aug 1, 2023 to Sep 1, 2023
    • Primary and study completion dates: Feb 28, 2026 to Mar 28, 2026
    v5
  4. Start date: Jun 1, 2023 to Aug 1, 2023
    • Primary and study completion dates: Dec 30, 2025 to Feb 28, 2026
    v4
  5. Start date: Apr 15, 2023 to Jun 1, 2023
    • Primary and study completion dates: Oct 30, 2025 to Dec 30, 2025
    v3
  6. Start date: Feb 15, 2023 to Apr 15, 2023
    • Primary and study completion dates: Aug 30, 2025 to Oct 30, 2025
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
Trial Details
NCT Number NCT05715229
Lead Sponsor Hackensack Meridian Health
Collaborators: MedSIR
Conditions
(from sponsor)		 Carcinoma, Non-Small-Cell Lung
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov