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Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jan 2027 to Sep 23, 2026 Eligibility criteria expanded, about 61 words · Collaborators: details revised at 1 of 1 entry Show 2 more changesShow less
    • Eligibility criteria expanded, about 61 words
    • Collaborators: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 4 of 4 sitesv14 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  3. Start date: Jul 11, 2023 to Jul 17, 2023 Eligibility criteria shortened, about 22 words · Study sites revised (4)v13 Show 2 more changesShow less
    • Eligibility criteria shortened, about 22 words
    • Study sites revised (4)

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv12
  5. Site contacts updated at 1 of 4 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Eligibility criteria expanded, about 361 wordsv9 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv8
  4. Site details revised at 1 of 4 sitesv7
  5. Study sites: 3 to 4v6
  6. Site details revised at 3 of 3 sitesv5
  7. Study title revisedv4 See this version in full on ClinicalTrials.gov ↗
  8. Eligibility criteria expanded, about 1,140 words Study title expanded, about 9 wordsv3 Show 1 more changeShow less
    • Study title expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2023 to Jul 11, 2023 · Site details revised at 3 of 3 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2023 to Jul 11, 2023
    • Site details revised at 3 of 3 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Although non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK), c-ros oncogene 1(ROS1), and ret proto-oncogene (RET) gene fusions initially respond well to tyrosine kinase inhibitor (TKI) therapies, acquired resistance is inevitable. In many of these cases, increased activation of the erythroblastic leukemia viral oncogene homologue (ERBB) or cMet pathways appears to be a bypass signaling mechanism that allows these cancer cells to circumvent the selective pressure from TKIs. Recent data have suggested that these pathways compensate for each other in situations where one pathway is inhibited, leading to "kinase switch" drug resistance. Thus, the expected inhibition of both pathways via treatment with the amivantamab and combination TKI combination may improve overall efficacy by limiting the compensatory pathway activation.
Trial Details
NCT Number NCT05845671
Lead Sponsor University of Colorado, Denver
Collaborators: Janssen Research & Development, LLC
Conditions Lung Cancer, Non Small Cell Lung Cancer
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov