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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
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)
Demographics
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.
Frequently asked questions
Is NCT06951646 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic antiangiogenic therapy disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify