Clinical trial NCT06842030: Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing
Official title: Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing to Improve Outcomes for Patients With Limited Metastatic Disease That Failed First-Line Systemic Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Personalized Medicine
Oligometastatic Disease
Feasibility
Lead sponsor: Good Samaritan Hospital Medical Center, New York
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility of n=20
Primary purpose: OTHER

Brief summary: This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.

Detailed description: Despite significant progress in solid tumor oncology, including widespread genomic testing, metastatic cancer remains largely incurable and results in approximately 90% of cancer deaths. In the context of systems biology, RNA transcriptome-based (RNA-seq) testing is utilized to identify master regulator proteins that are putative drivers of tumor progression. After extensive preclinical testing and validation, Darwin OncoTarget and OncoTreat has been developed as a commercially available next generation precision oncology test with preliminary evidence of efficacy in treatment-refractory advanced cancers. We designed this pilot trial to assess the feasibility of integrating Darwin OncoTarget and OncoTreat testing in patients with oligometastases receiving comprehensive involved site radiotherapy.

Eligible patients are adults with solid tumor oligometastases with up to 10 discrete tumors amenable to radiation therapy following prior first-line systemic therapy. Tumor biopsy is required to allow for precision medicine testing to supplement standard clinical management. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. Patients will either continue standard of care systemic therapy or proceed with an alternative FDA approved treatment informed by Darwin testing. This trial evaluates the feasibility and utility of integrating novel precision oncology testing in a community hospital setting.

This study will utilize precision oncology testing in the population of induced, recurrent or persistent oligometastases that currently have limited or largely ineffective systemic treatment options. This trial represents an early attempt at integrating next generation precision medicine testing and systems biology in the context of radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Patients age ≥18 years with metastatic solid tumor who are candidates for comprehensive involved site radiotherapy to all areas of disease seen on whole body imaging.
* Patients with brain metastases are eligible provided they qualify as oligometastases (up to 10 lesions based on the SABR-COMET-10 trial) and are treatable with radiotherapy to all areas of visible disease.
* Patients with adequate bone marrow (absolute neutrophil ≥1000, hemoglobin ≥ 9 g/dl, platelets ≥100,000), kidney (creatinine ≤1.5 times upper limit of normal) and liver (bilirubin ≤1.5 times upper limit of normal).
* Patients being treated by radiation oncology 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.
* Patients who are pregnant and/or breast feeding or those with severe uncontrolled cardiac, pulmonary, infectious or organic brain disease.

Primary outcomes:
measure: Feasibility: Test Performance Ability To Perform Test Versus Unable to Perform Test with Pathology Samples Needed >50% Tumor Tissue
timeFrame: Through study completion, an average of 2 years
measure: Feasibility: Percent Medication Change Versus No Medication Change Based on Treating Medical Oncologist Decision
timeFrame: Through study completion, an average of 2 years
measure: Feasibility: Percent Medication Procured Through Insurance and/or Compassionate Use Versus Unable to Attain
timeFrame: Through study completion, an average of 2 years
measure: Feasibility: Qualitative Measurement of Barriers Noted Throughout Study
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Systemic Therapy Change Compared to Standard of Care
timeFrame: Through study completion, an average of 2 years
measure: Progression-Free Survival
timeFrame: Patients will be followed as per standard of care, up to 5 years or until death. Event determined from date of enrollment until first documented progression or death from any cause, whichever came first, assessed up to 5 years.
Other outcomes:
Locations:
city: West Islip
country: United States
facility: Good Samaritan University Hospital
state: New York
Study officials:
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