An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network

Plain-language summary

This observational study evaluated the clinical utility of a test called the Oncomine Precision Assay in patients with advanced or metastatic non-small cell lung cancer. It enrolled previously untreated patients with measurable disease and non-squamous histology. This is a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Exactis Innovation

Start date

6/1/2021

Estimated completion

11/21/2023

Countries

Canada

Related genes

Locations

• Moncton, Canada
• Moncton, Canada
• Ottawa, Canada
• Toronto, Canada
• Montreal, Canada
• Sherbrooke, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Patients with NSCLC, which is (i) advanced or metastatic (stage IIIb/IV), (ii) non- squamous histology NSCLC as confirmed by local histopathology (mixed squamous and adenocarcinoma is allowed), and has (iii) radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm by CT scan
* No prior treatment for advanced or metastatic NSCLC, except for palliative radiation therapy to non-lung or non-thorax metastases. Patients who received palliative radiation therapy to metastases located within or approximately to the lung or thorax must be evaluated for eligibility.
* Willing and able to provide adequate blood sample prior to starting treatment.
* Willing to provide primary or metastatic tissue, if available.
* Signed and dated Research Ethics Board (REB)-approved informed consent form for Exactis-01 or PMT.
* Not pregnant or breastfeeding

Exclusion Criteria:

• Patients who have a history of another active cancer within the past 2 years from date of consent except cervical cancer in situ, basal cell carcinoma of the skin or another in situ carcinoma that is considered cured by the investigator.