Lung CancerNCT07624318

TROP2 NMR Concordance Study

An observational study of Lung Cancer, run by AstraZeneca at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Reference solution, Mixed solution and Local solution
Type of treatment: Medical device
How many people: 3,400 participants
Where: 4 sitesChina
Study dates: 13 Aug 2026to 15 Jun 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Age ≥18 years at sampling.
Histologically or cytologically documented non squamous NSCLC including:
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.
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.

Show all 18Show fewer

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.
-1.Age ≥18 years at sampling.
2.Histologically or cytologically documented non squamous NSCLC including:
(a)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%.
(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).
3. 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.
4. Informed Consent: Signed inform consent form or waived inform consent per EC requirements.

Who cannot join

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.).
1. Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC.
2. 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.).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

China4 sites, 4 recruiting

Research Site
Beijing, Beijing Municipality, 100730
Not yet recruiting
Research Site
Guangzhou, Guangdong, 510000
Not yet recruiting
Research Site
Shanghai, Shanghai Municipality, 200000
Not yet recruiting
Research Site
Shanghai, Shanghai Municipality, 200000
Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

Conditions: Lung Cancer
Being tested: Reference solution, Mixed solution, Local solution
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reference solutionDevice
Reference solution incorporates a TROP2 IHC assay, scanner and image analysis RUO algorithm into a solution for TROP2 NMR testing that has been well-established and validated. Pathologists may interpret the results; they may also perform quality control steps and negative selection of nontumor areas, if needed.
Mixed solutionDevice
Mixed solution for TROP2 NMR testing is defined as TROP2 IHC staining using identical clone with Reference, and stained slides will be transformed into digital images using KFBIO scanner (KF-PRO series). Images will be analysed by QCS algorithm RUO and the pathologist role is same as Reference solution.
Local solutionDevice
Local solution for TROP2 NMR testing is defined as TROP2 IHC staining using the identical assay with Reference, and stained slides will be transformed into digital images using KFBIO scanner (KF-PRO series). Images will be analysed by QCS algorithm RUO and the pathologist role is same as Reference solution.

Study groups in NCT07624318
Study group	Role	What they receive
The study is a cross-sectional study with no cohort design		The study is a cross-sectional study with no cohort design Receives: Device: Reference solution; Device: Mixed solution; Device: Local solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Stage 1 - Solution concordance in central lab: To evaluate TROP2 NMR concordance between Local solution and Reference solution in the central lab
The primary endpoint will be analysed in the ACS1 with evaluable Local solution result. The concordance between Local solution and Reference 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 Reference solution) × 100%;NPA = (number of patients with TROP2 NMR- based on both solutions)/(total number of patients with TROP2 NMR- based on Reference solution) × 100% ;OPA = (number of patients with concordant results based on both solutions)/(total number of patients) × 100%
Measured: Approximately 6 months after collection of the first slide.
Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Reference solution between sites and central lab
This primary endpoint will be analysed in the ACS2 with evaluable TROP2 NMR testing results by Reference solution from sites. The concordance will be summarized using PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Measured: Approximately 10 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 Reference solution in central lab
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.
Measured: Approximately 10 months after collection of the first slide.

Secondary outcomes (5)

Stage1：To evaluate TROP2 NMR concordance between Mixed solution and Reference solution in the central lab
For the secondary endpoint of concordance between Mixed solution and Reference 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.
Measured: Approximately 6 months after collection of the first slide.
Stage1：To evaluate IHC assay concordance using Reference scanner and QCS
For the secondary endpoint of concordance between Mixed solution and Reference 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.
Measured: Approximately 6 months after collection of the first slide.
Stage1：To evaluate scanner concordance using Reference IHC and QCS
For the secondary endpoint of concordance between Mixed solution and Reference 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.
Measured: Approximately 6 months after collection of the first slide.
Stage1：To evaluate QCS algorithm concordance using Reference IHC and scanner
For the secondary endpoint of concordance between Mixed solution and Reference 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.
Measured: Approximately 6 months after collection of the first slide.
Stage2：To evaluate TROP2 NMR concordance of Mixed solution in sites with Reference solution in the central lab
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.
Measured: Approximately 10 months after collection of the first slide.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 202615 Jun 2027

First posted3 Jun 2026
Study start13 Aug 2026
Primary completion15 Jun 2027 (estimated)
Study completion15 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 3,400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07624318
Sponsor's protocol ID: D9260R00030
Status last verified: May 2026
First submitted: 29 May 2026
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07624318
Acronym / sponsor ID: D9260R00030
Conditions: Lung Cancer
Study type: Observational
Recruitment status: Recruiting
Enrolment: 3,400 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 13 Aug 2026 (actual)
Primary completion: 15 Jun 2027 (estimated)
Study completion: 15 Jun 2027 (estimated)
First posted: 3 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
The study is a cross-sectional study with no cohort design	–	Device: Reference solution, Device: Mixed solution, Device: Local solutionThe study is a cross-sectional study with no cohort design

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (18 listed)

Age ≥18 years at sampling.
Histologically or cytologically documented non squamous NSCLC including:
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.
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.

Key exclusion criteria (4 listed)

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.).
1. Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC.
2. 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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reference solutionReference solution incorporates a TROP2 IHC assay, scanner and image analysis RUO algorithm into a solution for TROP2 NMR testing that has been well-established and validated. Pathologists may interpret the results; they may also perform quality control steps and negative selection of nontumor areas, if needed.	Device	The study is a cross-sectional study with no cohort design
Mixed solutionMixed solution for TROP2 NMR testing is defined as TROP2 IHC staining using identical clone with Reference, and stained slides will be transformed into digital images using KFBIO scanner (KF-PRO series). Images will be analysed by QCS algorithm RUO and the pathologist role is same as Reference solution.	Device	The study is a cross-sectional study with no cohort design
Local solutionLocal solution for TROP2 NMR testing is defined as TROP2 IHC staining using the identical assay with Reference, and stained slides will be transformed into digital images using KFBIO scanner (KF-PRO series). Images will be analysed by QCS algorithm RUO and the pathologist role is same as Reference solution.	Device	The study is a cross-sectional study with no cohort design

Primary outcome

Stage 1 - Solution concordance in central lab: To evaluate TROP2 NMR concordance between Local solution and Reference solution in the central lab
Time frame: 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 Reference 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 Reference solution) × 100%;NPA = (number of patients with TROP2 NMR- based on both solutions)/(total number of patients with TROP2 NMR- based on Reference solution) × 100% ;OPA = (number of patients with concordant results based on both solutions)/(total number of patients) × 100%
Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Reference solution between sites and central lab
Time frame: 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 Reference solution from sites. The concordance will be summarized using PPA, NPA, and OPA, with corresponding 95% confidence intervals.
Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Local solution in sites with Reference solution in central lab
Time frame: 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.

5 secondary outcomes

Stage1：To evaluate TROP2 NMR concordance between Mixed solution and Reference solution in the central lab
Time frame: Approximately 6 months after collection of the first slide.
Stage1：To evaluate IHC assay concordance using Reference scanner and QCS
Time frame: Approximately 6 months after collection of the first slide.
Stage1：To evaluate scanner concordance using Reference IHC and QCS
Time frame: Approximately 6 months after collection of the first slide.
Stage1：To evaluate QCS algorithm concordance using Reference IHC and scanner
Time frame: Approximately 6 months after collection of the first slide.
Stage2：To evaluate TROP2 NMR concordance of Mixed solution in sites with Reference solution in the central lab
Time frame: Approximately 10 months after collection of the first slide.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

zhiyong Liang principal investigator

Peking Union Medical College Hospital

shun Lu principal investigator

Shanghai Chest Hospital, Shanghai Jiaotong University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by AstraZeneca at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1 - Solution concordance in central lab: To evaluate TROP2 NMR concordance between Local solution and Reference solution in the central lab (time frame: Approximately 6 months after collection of the first slide.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07624318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.