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NCT06951646PHASE2RECRUITING

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

ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy: a Randomized, Open-label, Phase II Trial (CR1STAL-Adaptive)

Sponsor: Second Xiangya Hospital of Central South University + Nanjing Shihejiyin Technology, Inc., Akeso

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Non Small Cell Lung Cancer, Immune Checkpoint Inhibitors (ICIs)
Interventions
Ivonescimab, Docetaxel, Standard Treatment group
Enrollment
70 participants
Primary completion
Jul 2028
Study completion
Jun 2030
First posted
Apr 2025
Last updated
Mar 2026

Primary Endpoints (CT.gov)

Progression-Free Survival (PFS) in ctDNA-Positive Population

Time frame: 3 years

Secondary Endpoints

Overall Survival (OS)

Adverse Event

18-Month PFS Rate

Eligibility Criteria

Inclusion Criteria: 1. Sign written informed consent prior to any study-related procedures, be willing and able to complete the visits, treatment regimen, and laboratory tests specified in the schedule, and comply with other requirements of the study; 2. Aged ≥18 and ≤75 years old; 3. ECOG PS score 0-1; 4. Expected survival time ≥ 12 weeks; 5. Patients with stage IIIB-IIIC and IV non-small cell lung cancer confirmed by histology or cytology that cannot be treated locally (TNM lung cancer staging of the 9th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification); 6. There must be no EGFR gene-sensitive mutation, ALK gene fusion or ROS1 gene fusion in non-squamous carcinoma 7. Immunotherapy combined with platinum-containing doublet chemotherapy as a first-line standard treatment regimen; 8. Non-PD with PFS at screening enrollment is 11 to 15 months; 9. According to the Response Evaluation Criteria in Solid Tumors (

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov