TROP2 NMR Concordance Study
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a two-stage, multi-center study to compare concordance of Local solution and Mixed solution with a Reference solution in testing TROP2 NMR in untreated advanced NSCLC patients, as well as clinical application and robustness in real world labs. TROP2 NMR testing by QCS is composed of three main components: IHC assay, digital scanner and QCS algorithm. This study mainly focuses on end-to-end comparisons from different solutions or real-world labs. TROP2 NMR status results will be compared and the end-to-end concordance between solutions or labs will be assessed by PPA, NPA, and OPA. Three different solutions will be included in this study: Reference solution\\Local solution\\Mixed solution. Stage 1 will evaluate concordance of Local solution and Mixed solution with Reference solution in a central lab. Totally about 600 samples will be tested using Local solution, Mixed solution and Reference solution. When solutions concordance in stage 1 is achieved, the study will proceed to stage 2. Stage 2 will then assess the robustness and reproducibility of different solutions in real world pathology labs. About 1,000 TROP2 NMR positive (TROP2 NMR+) and 1,000 TROP2 NMR negative (TROP2 NMR-) samples will be identified by central lab using Reference solution, then these status-known samples will be distributed to approximately 50 participating site labs with 20 TROP2 NMR+ and 20 TROP2 NMR- per site, and subsequently tested at site labs in a blinded manner using Reference solution, and/or Local solution and/or Mixed solution, depending on Stage 1 results.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat w momencie pobrania próbki
- •Potwierdzony histologicznie lub cytologicznie rak płuca (typ niedrobnokomórkowy)
- •Zaawansowana choroba stadium IIIB, IIIC lub IV, która nie była dotąd leczona
- •Brak określonych mutacji genetycznych (EGFR, ALK, ROS1)
- •Wynik testu PD-L1 jest znany
- •Dostępna wystarczająca próbka tkanki (co najmniej 5-7 preparatów)
✗ Disqualifies
- •Pacjenci poniżej 18 roku życia
- •Rak płuca typu płaskonabłonkowego
- •Wcześniejsze leczenie systemowe raka płuca
- •Obecność określonych mutacji genetycznych kwalifikujących do leczenia ukierunkowanego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Research Site
Shanghai, China
Trial contact
AstraZeneca Clinical Study Information Center
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/10/2026.
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