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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160045 S027/ PAS001 |
| Date Original Protocol Accepted |
01/21/2022
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| Date Current Protocol Accepted |
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| Study Name |
PAS Clinical Study
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| Device Name |
Oncomine™ Dx Target Test
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| Clinical Trial Number(s) |
NCT02609776
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the clinical validation study is to provide evidence in support of the safety and effectiveness of the ODxT Test when used in accordance with its indications for use and product labeling. The study will support the use of the ODxT Test as an aid to determine EGFR exon 20- insertion mutation status in identifying patients with NSCLC screened and enrolled for treatment with JNJ-372 using multiple Clinical Trial Assays (CTAs) in study JNJ-61186372.
The purpose of this PAS is to:
1) Supplement the Olympic clinical study with minimum of approximately 24 additional samples to assess the analytical accuracy of the ODxT Test by evaluating its agreement with an orthogonal test method(s) using EGFR exon 20 insertion-positive clinical samples obtained from the dose expansion cohort of Janssen’s Phase 1/2 clinical trial (Clinical Study Protocol JNJ-61186372);
2) To assess the clinical effectiveness of the ODxT Test in selecting patients for treatment with JNJ-372 administered in subjects with locally advanced or metastatic NSCLC, by evaluating:
a. the concordance between the CTA results and the ODxT Test results
b. the objective response rate (ORR) based on ODxT Test results;
Design:
A minimum of approximately 24 EGFR exon 20 insertion mutation-positive NSCLC clinical trial samples collected from the dose expansion Cohort D of Janssen’s clinical study will be tested by both the ODxT Test (CDx) and the TST170 Assay (comparator).
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| Study Population |
The primary analyses population includes specimens with valid ODxT Test results from the efficacy evaluable registrational cohort of Janssen’s clinical study.
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| Sample Size |
A minimum of approximately 24 EGFR exon 20 insertion mutation-positive NSCLC clinical trial samples collected from the dose expansion Cohort D of Janssen’s clinical study will be tested by both the ODxT Test and the TST170 Assay.
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| Key Study Endpoints |
The primary endpoint will be overall response rate (ORR) by RECIST 1.1 as assessed by independent radiologic review and a description of the duration of response (DoR).
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| Follow-up Visits and Length of Follow-up |
The efficacy evaluable analysis set will consist of subjects who received at least one dose of study drug and either had at least 2 post-baseline efficacy disease assessments, or discontinued treatment for any reason, or had disease progression/ death prior to the 2nd post-baseline disease assessment. Moreover, subjects in the efficacy evaluable analysis set for this diagnostic study include only those treated at the recommend phase 2 dose (RP2D) with metastatic NSCLC (metastases within 12 months from last platinum-based chemotherapy use) positive for Exon 20 Insertion whose disease progressed on or after platinum-based chemotherapy. This analysis set will be used for efficacy analysis unless otherwise stated.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
24
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| Actual Number of Sites Enrolled |
14
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| Patient Follow-up Rate |
At least 2 post-baseline efficacy disease assessments
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| Final Safety Findings |
The testing for this clinical validation study was conducted retrospectively on archived study specimens. No treatment decisions were made based on any of these test results; therefore, there were no unanticipated adverse device events related to the study products or procedures to subjects or operators.
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| Final Effect Findings |
The Blinded Independent Central Review (BICR)-assessed confirmed overall response rate (confirmed Complete Response + confirmed Partial Response) was 41.7% in the primary efficacy population with EGFR exon 20 insertions detected by the ODxT Test (n=24) versus 41.5% in the primary efficacy population (n-41) based on the Clinical Trial Assays (Local tests).
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| Study Strengths & Weaknesses |
N/A
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| Recommendations for Labeling Changes |
Yes. The labeling supplement should include a summary of the post-approval study design and results.
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