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Trop2 NMR Concordance Study (ALINEAR)

29 maja 2026 zaktualizowane przez: AstraZeneca

A Two-stage, Multi-center Concordance Study of Trophoblast Cell Surface Antigen 2 (TROP2) Normalized Membrane Ratio (NMR) in Non-Small Cell Lung Cancer Without Systemic Therapy (TROP2 ALINEAR)

This is a two-stage, multi-center study to compare concordance of Local solution and Mixed solution with "Ground-truth" Ventana 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: Ventana solution\Local solution\Mixed solution.

Stage 1 will evaluate concordance of Local solution and Mixed solution with Ventana "Ground-truth" solution in a central lab. Totally about 600 samples will be tested using Local solution, Mixed solution and Ventana 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 Ventana 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 Ventana solution, and/or Local solution and/or Mixed solution, depending on Stage 1 results.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Because our study is a cross-sectional study, no Discontinuation criteria were set for stage 1&stage2. The target of stage2 is to accrue a minimum of 1,000 positive samples and 1,000 negative samples at the central lab. Enrollment will be terminated once these accrual targets are achieved; no further specimens will be collected thereafter, even if the total number of specimens does not reach 2,800, or it is also possible that the final enrollment may exceed 2,800 participants.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

3400

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100730
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510000
        • Research Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chiny, 200000
        • Research Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The target population of interest in this study is participants with untreated advanced NSCLC without actionable genomic alterations (ie, alterations in genes with approved therapies available). Participants provide archival tumour tissue samples less than two years at enrollment with signed inform consent form or waived inform consent per EC requirements.

Opis

Inclusion Criteria:

  • Age ≥18 years at sampling.

  • Histologically or cytologically documented non squamous NSCLC including:

    1. Stage IIIB or IIIC disease not amenable for surgical resection or definitive chemoradiation, or Stage IV metastatic NSCLC disease at the time of sampling who have not received any systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC.

Participants who provide surgical samples for early-stage disease (Stage I to IIIA) are eligible. The capping for surgical samples is 70% and biopsy samples 30%.

  • 2. (b) Lacks sensitising EGFR tumour tissue mutation (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), as well as ALK and ROS1 rearrangements.

    (c) Has no documented tumour genomic alteration results in NTRK, BRAF, RET, MET or HER2, KRAS oncogenes for which there are locally approved and available targeted first-line therapies.

    (d) Participants have documented PD-L1 status with TPS (or TC).

  • Willing to provide and have adequate tissue samples for biomarker testing, at least ≥5 FFPE slides for Stage 1, and at least ≥7 FFPE slides for Stage 2. Archival surgical samples less than 2 years before enrollment are eligible.
  • Informed Consent: Signed inform consent form or waived inform consent per EC requirements.

Exclusion Criteria:

  • Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC.
  • At the time of tissue acquisition, the subject has the following known conditions: active tuberculosis infection, or clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
The study is a cross-sectional study with no cohort design
Urządzenie: Ventana solution
Ventana solution for TROP2 NMR testing is defined as TROP2 IHC staining using VENTANA® TROP2 (EPR20043) RxDx, and stained slides will be transformed into digital images using VENTANA® DP 600 scanner. Images will be analyzed by VENTANA QCS algorithm RUO and the results will be reviewed by the pathologist to accept or reject the analysis. Ventana solution will be the reference test (Ground-truth) in this concordance study.
Urządzenie: Local solution
Local solution for TROP2 NMR testing is defined as TROP2 IHC staining using identical clone as class I TROP2 IHC assay, and stained slides will be transformed into digital images using KFBIO scanner (KF-PRO series). Images will be analyzed by Dipath QCS algorithm RUO and the results will be reviewed by the pathologist to accept or reject the analysis.
Urządzenie: Mixed solution
Mixed solution for TROP2 NMR testing is defined as TROP2 IHC staining using VENTANA® TROP2 (EPR20043) RxDx, and stained slides will be transformed into digital images using KFBIO scanner (KF-PRO series). Images will be analysed by Dipath QCS algorithm RUO and the results will be reviewed by the pathologist to accept or reject the analysis.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Stage 1 - Solution concordance in central lab: To evaluate TROP2 NMR concordance between Local solution and Ventana solution in the central lab
Ramy czasowe: Approximately 6 months after collection of the first slide.
The primary endpoint will be analysed in the ACS1 with evaluable Local solution result. The concordance between Local solution and Ventana solution will be descriptive through calculation of Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), and Overall Percentage Agreement (OPA). These metrics will be computed using two-by-two contingency tables and reported with corresponding 95% Clopper-Pearson confidence intervals. Cohen's kappa coefficient and 95% CI will also be used to assess the degree of agreement by chance.PPA = (number of patients with TROP2 NMR+ based on both solutions)/(total number of patients with TROP2 NMR+ based on Ventana solution) × 100%;NPA = (number of patients with TROP2 NMR- based on both solutions)/(total number of patients with TROP2 NMR- based on Ventana solution) × 100% ;OPA = (number of patients with concordant results based on both solutions)/(total number of patients) × 100%
Approximately 6 months after collection of the first slide.
Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Local solution in sites with Ventana solution in central lab
Ramy czasowe: Approximately 10 months after collection of the first slide.
This primary endpoint will be analysed in the ACS2 with evaluable TROP2 NMR testing results from Local solution. The concordance will be summarized using the same statistical metrics as the primary endpoint in stage 1, including PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Approximately 10 months after collection of the first slide.
Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Ventana solution between sites and central lab
Ramy czasowe: Approximately 10 months after collection of the first slide.
This primary endpoint will be analysed in the ACS2 with evaluable TROP2 NMR testing results by Ventana solution from sites. The concordance will be summarized using PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Approximately 10 months after collection of the first slide.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Stage1：To evaluate TROP2 NMR concordance between Mixed solution and Ventana solution in the central lab
Ramy czasowe: Approximately 6 months after collection of the first slide.
For the secondary endpoint of concordance between Mixed solution and Ventana solution, the analysis will be performed in the ACS1 with evaluable Mixed solution results. The component concordance will be analysed in the CCS, from which a subset of data will be extracted for each component-specific concordance. The concordance will be summarized using the same statistical metrics as the primary endpoint, including PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Approximately 6 months after collection of the first slide.
Stage1：To evaluate IHC assay concordance using Ventana scanner and QCS
Ramy czasowe: Approximately 6 months after collection of the first slide.
For the secondary endpoint of concordance between Mixed solution and Ventana solution, the analysis will be performed in the ACS1 with evaluable Mixed solution results. The component concordance will be analysed in the CCS, from which a subset of data will be extracted for each component-specific concordance. The concordance will be summarized using the same statistical metrics as the primary endpoint, including PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Approximately 6 months after collection of the first slide.
Stage1：To evaluate scanner concordance using Ventana IHC and local QCS
Ramy czasowe: Approximately 6 months after collection of the first slide.
For the secondary endpoint of concordance between Mixed solution and Ventana solution, the analysis will be performed in the ACS1 with evaluable Mixed solution results. The component concordance will be analysed in the CCS, from which a subset of data will be extracted for each component-specific concordance. The concordance will be summarized using the same statistical metrics as the primary endpoint, including PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Approximately 6 months after collection of the first slide.
Stage1：To evaluate QCS algorithm concordance using Ventana IHC and scanner
Ramy czasowe: Approximately 6 months after collection of the first slide.
For the secondary endpoint of concordance between Mixed solution and Ventana solution, the analysis will be performed in the ACS1 with evaluable Mixed solution results. The component concordance will be analysed in the CCS, from which a subset of data will be extracted for each component-specific concordance. The concordance will be summarized using the same statistical metrics as the primary endpoint, including PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Approximately 6 months after collection of the first slide.
Stage2：To evaluate TROP2 NMR concordance of Mixed solution in sites with Ventana solution in the central lab
Ramy czasowe: Approximately 10 months after collection of the first slide.
The secondary endpoint will be analysed in the ACS2 with evaluable TROP2 NMR testing results from Mixed solution in sites. The concordance will be summarized using the same statistical metrics as above.
Approximately 10 months after collection of the first slide.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 czerwca 2027

Ukończenie studiów (Szacowany)

15 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

3 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D9260R00030

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Ramy czasowe udostępniania IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Kryteria dostępu do udostępniania IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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