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A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 138 to 194 Secondary endpoints: details revised at 5 of 16 entries · Site details revised at 14 of 29 sites · Eligibility criteria shortened, about 5 words · 1 morev4 Show 4 more changesShow less
    • Secondary endpoints: details revised at 5 of 16 entries
    • Site details revised at 14 of 29 sites
    • Eligibility criteria shortened, about 5 words
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 11 to 29v3
  3. Lead sponsor: AnHeart Therapeutics Inc. to Nuvation Bio Inc. Trial status: Not Yet Recruiting to Recruiting · Study sites: 0 to 11 · Start date changed from estimate of Sep 2024 to Nov 27, 2024 · 1 morev2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 11
    • Start date changed from estimate of Sep 2024 to Nov 27, 2024
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase 3, randomized, open-label, comparative, multicenter, international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity (i.e., ROS1+) and who have not previously received an ROS1-targeted TKI (i.e., ROS1-TKI-naïve). Approximately 194 ROS-1 TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: * Arm A: Taletrectinib monotherapy at 600 mg once daily (QD); * Arm B: Crizotinib monotherapy at 250 mg twice daily (BID). Each cycle duration will be 28 days. Participants will be stratified by the presence of intracranial metastases at baseline (Yes versus No) and prior chemotherapy use for locally advanced or metastatic disease (Yes versus No). For the purposes of stratification, prior chemotherapy is defined as completion of ≥1 cycle of chemotherapy in the locally advanced or metastatic setting. Participants will be treated until they experience progressive disease (PD) assessed by the BIRC, intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC.
Trial Details
NCT Number NCT06564324
Lead Sponsor Nuvation Bio Inc.
Conditions Non Small Cell Lung Cancer
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov