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
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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