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 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.

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	2026-03-10
Primary Completion	2028-07-01 (estimated)
Study Completion	2030-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-09