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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240037 / PAS001 |
| Date Original Protocol Accepted |
07/11/2025
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| Date Current Protocol Accepted |
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| Study Name |
PAS Clinical Study
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| Device Name |
VENTANA MET (SP44) RxDx Assay
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| Clinical Trial Number(s) |
NCT03539536
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective 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 |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to confirm in a post market setting the clinical effectiveness of VENTANA MET (SP44) RxDx Assay as a companion diagnostic (CDx) device for the identification of NSCLC patients with MET protein who may benefit from treatment with telisotuzumab vedotin.
The primary objectives of this study are to determine the prevalence of subjects whose MET-positivity at the greater than or equal to 50% strong TC cutoff is driven by different cellular compartments (predominant staining pattern: membrane-only, membrane and cytoplasm, and cytoplasm-only) and to determine efficacy of telisotuzumab vedotin for MET-positive subjects at the greater than or equal to 50% strong TC cutoff.
The study design includes two cohorts of patients with NSCLC treated with telisotuzumab vedotin that come from either study M25-274, “A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens In Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advance/Metastatic Non-Squamous Non-Small Cell Lung Cancer.”, or study M18-868, “A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer.”:
- 13 – 15 patients from AbbVie study protocol M25-274 will be included in the primary efficacy analysis with a positive MET status at the =50% strong TC cutoff.
- 45 patients from the M25-274 Phase 2 study, inclusive of the 15 patients discussed above, and all available patients pre-screened for the M18-868 Phase 3 study between January 2025 and April 2027 will be included in the primary prevalence analysis with a positive MET status at the greater than or equal to 50% strong TC cutoff.
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| Study Population |
The study consists of 45 participants from study M25-274 and all available patients pre-screened for the M18-868 Phase 3 study between January 2025 and April 2027. Patients in these studies have previously treated MET overexpressing, EGFR wildtype, locally advanced/metastatic non-squamous non-small cell lung cancer.
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| Sample Size |
The study consists of 45 participants from study M25-274 and all available patients pre-screened for the M18-868 Phase 3 study between January 2025 and April 2027. The total number of subjects included in this study will be dependent on the subject enrollment rates.
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| Key Study Endpoints |
All patients enrolled into Arm 1 of the M25-274 Phase 2 study (1.9 mg/kg Q2W) (with a positive MET status at the greater than or equal to 50% strong TC cutoff) by May 2027 who have efficacy data (ORR) available will be included in the primary efficacy analysis.
All patients enrolled (approximately 45) in the M25-274 Phase 2 study (with a positive MET status at the =50% strong TC cutoff) by May 2027 and all available enrolled patients who were pre-screened between January 2025 and April 2027 in the M18-868 Phase 3 study (with a positive MET status at the greater than or equal to 50% strong TC cutoff) will be included in the primary prevalence analysis.
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| Follow-up Visits and Length of Follow-up |
Patients from M25-278 included in the efficacy assessment will have been followed for at least 12 weeks (two scheduled tumor assessments) from the first dose.
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