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ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 1, 2025 to Mar 10, 2026 · Study sites: 13 to 20 · Interventions: Ivonescimab plus docetaxel (Drug), Standard Treatment (Other) to Docetaxel (Drug), Ivonescimab (Drug), Standard Treatment group (Other) · 2 morev2 Show 5 more changesShow less
    • Start date: Jun 1, 2025 to Mar 10, 2026
    • Study sites: 13 to 20
    • Interventions: Ivonescimab plus docetaxel (Drug), Standard Treatment (Other) to Docetaxel (Drug), Ivonescimab (Drug), Standard Treatment group (Other)
    • Secondary endpoints: 7 to 10
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The CR1STAL-Adaptive study is a randomized, open-label, phase II multicenter interventional trial designed to evaluate the safety and efficacy of Ivonescimab (PD-1/VEGF bispecific antibody) combined with docetaxel versus standard treatment in patients with advanced NSCLC who have achieved long-term benefit from first-line immune checkpoint inhibitors (ICIs), but are ctDNA-MRD positive. Building upon insights from previous CR1STAL study (NCT05198154), the CR1STAL-Adaptive study supports the development of precision-guided, adaptive treatment strategies to delay progression and improve outcomes in NSCLC patients with a long-term response to immunotherapy. It represents a step forward in integrating dynamic molecular monitoring with individualized intervention strategies in the era of immunotherapy.
Trial Details
NCT Number NCT06951646
Lead Sponsor Second Xiangya Hospital of Central South University
Collaborators: Nanjing Shihejiyin Technology, Inc., Akeso
Conditions Non Small Cell Lung Cancer, Immune Checkpoint Inhibitors (ICIs)
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov