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Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 37 to 34v10
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 84 to confirmed 54 · Primary completion date changed from estimate of Mar 2025 to Feb 26, 2025 · Completion date: Jan 2026 to Feb 2027 · 1 morev9 Show 4 more changesShow less
    • Enrollment target: estimated 84 to confirmed 54
    • Primary completion date changed from estimate of Mar 2025 to Feb 26, 2025
    • Completion date: Jan 2026 to Feb 2027
    • Site details revised at 37 of 37 sites
  3. Study sites: 38 to 37 Eligibility criteria expanded, about 29 words · Secondary endpoints: details revised at 2 of 10 entriesv8 Show 2 more changesShow less
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 2 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 39 to 38v7
  5. Primary completion date: Jul 2023 to Mar 2025 Completion date: Dec 2026 to Jan 2026v6 Show 1 more changeShow less
    • Completion date: Dec 2026 to Jan 2026
Show 4 earlier versionsHide 4 earlier versions
  1. Site contacts updated at 38 of 39 sitesv5
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2021 to Mar 19, 2021 · Site details revised at 39 of 39 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2021 to Mar 19, 2021
    • Site details revised at 39 of 39 sites
  3. Start date: Jan 2021 to Mar 2021v3
  4. Eligibility criteria shortened, about 21 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ROS1 rearrangements are present in 1-2% of NSCLC cases and define a distinct molecular subgroup. Like ALK (anaplastic lymphoma kinase) rearrangements in NSCLC, ROS1 fusions confer sensitivity to the inhibitor crizotinib. Crizotinib, which is a tyrosine kinase inhibitor (TKI), has been shown to be effective in tumors in several retrospective studies. Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC. This indication is based on the results of pooled data from several trials. Together, these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion. However, despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC, patients will develop resistance to these tyrosine kinase inhibitors. Lorlatinib is a new and potent ROS1 / ALK inhibitor optimized to penetrate the blood-brain barrier. A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation. In this situation, lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response. Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations, lorlatinib could be a treatment of choice in ROS1-positive NSCLC.
Trial Details
NCT Number NCT04621188
Lead Sponsor Intergroupe Francophone de Cancerologie Thoracique
Conditions Non Small Cell Lung Cancer Metastatic
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov