Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

(CYBRID-01 Trial)

Recruiting at 5 trial locations

Overseen By Jonathan Oliner, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elephas

Must not be taking: Antiretrovirals

Disqualifiers: Auto-immune disease, Immunocompromised, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Fred Hausheer, MD, FACP

Principal Investigator

Elephas

Are You a Good Fit for This Trial?

Inclusion Criteria

Suspected of or diagnosed with non-small cell lung cancer (NSCLC).

Written informed consent and HIPAA authorization for release of personal health information prior to registration.

ECOG ≤ 3.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Collection

Participants undergo biopsy procedures to collect small 3D Live Tumor Fragments (LTFs) for diagnostic platform development

1-2 weeks

Observational

Participants' clinical responses to ICIs are observed and compared to the platform's predictive AI score

3 years

Follow-up

Participants are monitored for safety and effectiveness after the observational phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Core needle biopsy

How Is the Trial Designed?

Group I: Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Elephas

Lead Sponsor

Trials

2

Recruited

420+

Beaufort CRO

Industry Sponsor

Trials

2

Recruited

3,200+