A Phase 4 interventional study of Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE. in Advanced Solid Tumors, sponsored by NING LI. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by NING LI · Phase 4, Interventional, and Treatment
This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients, including including demographics, clinical information, and multi-omics data. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.
This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. The study will prospectively collect patient data of multiple dimensions, including demographics, clinical information (pathological classification, tumor staging, imaging findings, previous treatment regimens and their effectiveness, performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, transcriptome sequencing, etc.). A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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This arm involves the prospective collection of individual patient data, including demographic information, clinical details (such as pathological classification, tumor staging, imaging findings, prior treatments and their efficacy, and performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, and transcriptome sequencing). An artificial intelligence model (namely, Quasar) integrates this multidimensional information to prioritize standard treatment options and identify the optimal personalized treatment plan for each patient. Based on the AI-recommended treatment list, the final treatment plan is jointly selected by the patient and the physician. If treatment adjustments are required due to tumor progression, intolerance, or other reasons, the AI model will generate a new optimal treatment plan based on updated patient characteristics. This iterative process continues until the patient withdraws from the study.
Drug: Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE.
Quasar is a biologically-informed multi-agent system developed based on multi-omics and multi-modal data. By integrating multidimensional information such as patients' demographic, clinical, and omics data (including DNA genotyping, whole-exome sequencing, transcriptome sequencing, etc.), it prioritizes standard treatment plans and recommends the optimal personalized treatment plan. Including targeted drugs, chemotherapy, immunotherapy approved by China CDE.
Also known as: KEYTRUDA et al.
Progression-free survival (PFS)
Defined as the time from enrollment to documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Time frame: Every 6 weeks, up to 2 years since enrollment
Overall response rate (ORR)
Defined as the proportion of cases showing the best response of complete response (CR) or partial response (PR) (i.e., CR+PR) per RECIST 1.1 (based on CT, MRI or PET-CT), during the period from the start of the investigational drug to withdrawal from the trial.
Time frame: Every 6 weeks, up to 2 years since enrollment
Duration of response (DoR)
Defined as the time from the first documented response, i.e. CR or PR, per RECIST 1.1, to disease progression or death from any cause, whichever occurs first.
Time frame: Every 6 weeks, up to 2 years since enrollment
Time to treatment failure (TTF)
Defined as the time from the start of enrollment to the termination of treatment for any reason, including disease progression per RECIST 1.1, treatment toxicity, or death.
Time frame: Every 6 weeks, up to 2 years since enrollment
Time to progression (TTP)
Defined as the time from enrollment to the occurrence of objective tumor progression per RECIST 1.1, excluding death.
Time frame: Every 6 weeks, up to 2 years since enrollment
Best of response (BoR)
Defined as the best therapeutic effect recorded from the start of treatment until disease progression or recurrence, per RECIST 1.1.
Time frame: Every 6 weeks, up to 2 years since enrollment
Treatment-emergent adverse events (TEAE)
Defined as adverse events that emerge or worsen in severity following the initiation of intervention, per CTCAE 5.0.
Time frame: Every 6 weeks, up to 2 years since enrollment
Plan to share: No
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