OncoMatch/Clinical Trials/NCT06951646
ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)
Is NCT06951646 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivonescimab and Docetaxel for non small cell lung cancer.
Treatment: Ivonescimab · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor — first-line
Immunotherapy combined with platinum-containing doublet chemotherapy as a first-line standard treatment regimen
Cannot have received: systemic antiangiogenic therapy
Subjects who have received systemic antiangiogenic therapy
Lab requirements
Blood counts
absolute neutrophil count ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥9.0 g/dL (no blood transfusion or erythropoietin-dependent administration within 7 days)
Kidney function
serum creatinine ≤1.5×ULN or Cr clearance ≥50 mL/min; urine protein <2+ or 24-hour urine protein quantification <1g
Liver function
total bilirubin ≤1.5×ULN; for liver metastasis or Gilbert's syndrome, TBIL ≤3×ULN; ALT/AST ≤2.5×ULN (no liver mets), ALT/AST ≤5×ULN (liver mets)
Cardiac function
left ventricular ejection fraction (LVEF) ≥ 50%
Meet the following laboratory indicators (within 14 days before the first treatment): Routine blood test: absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin content ≥9.0 g/dL (no blood transfusion or erythropoietin-dependent administration within 7 days). Liver function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); for patients with liver metastasis or confirmed/suspected Gilbert's syndrome, TBIL ≤3×ULN; in the absence of liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. For patients with liver metastasis, ALT or AST ≤5×ULN. Renal function: serum creatinine (Cr) ≤ 1.5 times ULN or Cr clearance ≥ 50 mL/min (Cockcroft-Gault formula), and urine routine test results show urine protein (UPRO) <2+ or 24-hour urine protein quantification <1g. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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