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Trop2 NMR Concordance Study (ALINEAR)

2026년 5월 29일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

3400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
The study is a cross-sectional study with no cohort design
장치: 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.
장치: 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.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Stage 1 - Solution concordance in central lab: To evaluate TROP2 NMR concordance between Local solution and Ventana solution in the central lab
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Stage1：To evaluate TROP2 NMR concordance between Mixed solution and Ventana solution in the central lab
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2027년 6월 15일

연구 완료 (추정된)

2027년 6월 15일

연구 등록 날짜

최초 제출

2026년 5월 29일

QC 기준을 충족하는 최초 제출

2026년 5월 29일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 29일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D9260R00030

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐암에 대한 임상 시험

Ventana solution에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Taiwan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다