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Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) for Non-Small Cell Lung Cancer (CYBRID-01 Trial)

N/A
Recruiting
Research Sponsored by Elephas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors
Secondary outcome measures
Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC)Experimental Treatment1 Intervention
Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria: 1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer. 2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease 3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study. 4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.

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Who is running the clinical trial?

ElephasLead Sponsor
1 Previous Clinical Trials
216 Total Patients Enrolled
Beaufort CROIndustry Sponsor
1 Previous Clinical Trials
3,000 Total Patients Enrolled
Jonathan Oliner, MD, PhDStudy DirectorElephas
~113 spots leftby Dec 2026
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