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De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction

Study acronym: DIAL
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 1, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jan 2025 to May 2025 Site contacts updated at 1 of 44 sitesv7 Show 1 more changeShow less
    • Site contacts updated at 1 of 44 sites
  2. Primary completion date: Jun 1, 2024 to Jan 2025 Site contacts updated at 1 of 44 sitesv6 Show 1 more changeShow less
    • Site contacts updated at 1 of 44 sites
  3. Primary completion date: Jun 1, 2023 to Jun 1, 2024v5
  4. Study sites: 38 to 44 Eligibility criteria revisedv4 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 37 to 38 Eligibility criteria shortened, about 1 word · Study description expanded, about 1 wordv3 Show 2 more changesShow less
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2022 to May 2, 2022 · Site details revised at 37 of 37 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2022 to May 2, 2022
    • Site details revised at 37 of 37 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials. The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.
Trial Details
NCT Number NCT05255302
Lead Sponsor Intergroupe Francophone de Cancerologie Thoracique
Conditions Metastatic NSCLC
Enrollment 1,360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov