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

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

Trial Details

NCT ID
NCT06951646
Phase
PHASE2
Sponsor
Second Xiangya Hospital of Central South University
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Ivonescimab
  • Docetaxel
  • Standard Treatment group
Locations (sample)
  • Changsha, China|28.19874,112.97087
  • Changsha, China|28.19874,112.97087
  • Changsha, China|28.19874,112.97087
  • Changsha, China|28.19874,112.97087
  • Changsha, China|28.19874,112.97087

Key Eligibility Criteria

  • Sign written informed consent prior to any study-related procedures, be willing and able to complete the visits, treatment regimen, and laboratory …
  • Aged ≥18 and ≤75 years old;
  • ECOG PS score 0-1;
  • Expected survival time ≥ 12 weeks;

For full eligibility, visit ClinicalTrials.gov.

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