Precision Medicine for Metastatic Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Good Samaritan Hospital Medical Center, New York

Disqualifiers: Pregnancy, Severe cardiac, Pulmonary, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two tests, OncoTarget and OncoTreat, can improve treatment for individuals with metastatic cancer (cancer that has spread to other parts of the body). It focuses on patients receiving radiation therapy with a small number of tumors. The goal is to assess whether these tests can help doctors select better treatments and improve patient outcomes. This study suits those with metastatic solid tumors who are receiving radiation at Good Samaritan University Hospital and have tumors treatable with radiation. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future cancer treatment strategies.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that the decision on medication use will be made by your treating oncologist based on the precision medicine testing results.

What prior data suggests that the Darwin OncoTarget and OncoTreat testing is safe for use in precision medicine?

Research has not yet provided specific safety information for the precision medicine treatments Darwin OncoTarget and OncoTreat. These treatments are part of a trial evaluating their effectiveness alongside other cancer treatments. As this study is in an early stage, limited information exists regarding their safety for participants.

However, the trial is closely monitored, and any side effects or safety issues will be carefully recorded and addressed. Prospective participants should consult their doctor for more information tailored to their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Darwin OncoTarget and OncoTreat because they offer a personalized approach to treating metastatic disease. Unlike standard treatments, which often include a one-size-fits-all approach like chemotherapy, these tests analyze the genetic makeup of a patient's cancer to tailor the treatment specifically to their needs. This precision medicine approach aims to improve outcomes by targeting the unique characteristics of an individual's cancer, potentially increasing effectiveness and reducing side effects compared to conventional therapies.

What evidence suggests that Darwin OncoTarget and OncoTreat testing might be effective for metastatic disease?

Research has shown that Darwin OncoTarget and OncoTreat tests can improve outcomes for patients with certain metastatic cancers. Some studies have found that these precision medicine tests, combined with targeted local treatments, can extend the time patients live without cancer progression. In this trial, all participants will receive the same study intervention, which includes standard radiation to all visible disease areas. Systemic therapy will be determined by the medical oncologist using supplemental information from the Darwin OncoTarget and OncoTreat tests. These tests assist doctors in selecting more effective treatments based on the tumor's genetic details. Although these tests are still under study, early results have been promising for patients with challenging cancer cases. This approach aims to customize treatments for each patient, potentially leading to better outcomes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with oligometastasis from various solid tumors who are undergoing radiation therapy. They must have a tumor biopsy before precision medicine testing and be willing to potentially change their standard treatment based on the test results.

Inclusion Criteria

I have up to 10 brain tumors treatable with radiotherapy.

My blood, kidney, and liver tests are within safe ranges.

I am receiving radiation therapy at Good Samaritan University Hospital.

Exclusion Criteria

Patients with an estimated median survival of less than 6 months using the published and validated NEAT methodology

I am not pregnant, breastfeeding, and do not have severe heart, lung, infectious diseases or brain disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy and Testing

Mandatory tumor biopsy is performed for precision medicine testing using Darwin OncoTarget and OncoTreat

1-2 weeks

1 visit (in-person)

Radiation Therapy

Participants receive comprehensive involved site radiotherapy to all areas of visible disease

6-8 weeks

Multiple visits (in-person)

Systemic Therapy

Systemic therapy is administered based on standard of care or informed by Darwin testing

Variable, based on treatment plan

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Regular visits as per standard of care

What Are the Treatments Tested in This Trial?

Interventions

• Darwin OncoTarget and OncoTreat

Trial Overview The trial tests OncoTarget and OncoTreat, which are precision medicine tests performed on biopsied tumor tissue. These tests aim to guide oncologists in deciding whether to continue standard care or switch to a personalized treatment plan.

How Is the Trial Designed?

Group I: Feasibility Experimental Treatment 1 Intervention

All study participants will get the same study intervention. It will include the usual radiation to all areas of visible disease. Systemic therapy will be determined by your medical oncologist with the supplemental information provided by the Darwin OncoTarget and OncoTreat test.

Who Is Running the Clinical Trial?

Good Samaritan Hospital Medical Center, New York

Lead Sponsor

Trials

7

Recruited

6,900+

Published Research Related to This Trial

The repository includes 79 patient-derived xenograft (PDX) models of lung cancer, primarily non-small cell lung cancer (NSCLC), which have been thoroughly characterized for their genomic and clinical features, making them a valuable resource for testing new cancer therapies.

These PDX models maintain key characteristics of the original patient tumors and demonstrate expected treatment responses, confirming their utility as reliable preclinical platforms for cancer research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Genomically and Clinically Annotated Patient-Derived Xenograft Resource for Preclinical Research in Non-Small Cell Lung Cancer. Woo, XY., Srivastava, A., Mack, PC., et al.[2022]

Citations

1. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0325769

Feasibility trial of Darwin OncoTreat and OncoTarget precision ... Two randomized trials demonstrated improved progression-free survival and overall survival when comprehensive local consolidative therapy is added to systemic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40498747/

Feasibility trial of Darwin OncoTreat and OncoTarget ... Feasibility trial of Darwin OncoTreat and OncoTarget precision medicine testing to improve outcomes for patients with limited metastatic disease ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12157055/

Feasibility trial of Darwin OncoTreat and OncoTarget ... Feasibility trial of Darwin OncoTreat and OncoTarget precision medicine testing to improve outcomes for patients with limited metastatic disease

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/581821

Feasibility Trial of Darwin OncoTreat and OncoTarget ... Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, ...

5. withpower.com withpower.com/trial/phase-personalized-medicine-2-2025-f0067

Precision Medicine for Metastatic Disease Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, ...

6. stacks.cdc.gov stacks.cdc.gov/view/cdc/129436/cdc_129436_DS1.pdf

A transcriptome-based precision oncology ... Based on benchmarking of 11,289 primary tumors from TCGA, as well as over 100 prospectively collected samples from patients with metastatic and ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/30/NCT06842030/ICF_000.pdf

Feasibility Trial of Darwin OncoTreat and OncoTarget ... You will undergo standard treatment for limited metastatic cancer while being assessed with. Darwin OncoTarget and OncoTreat testing. If your ...