TROP2 NMR Concordance in Advanced NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multi-center study compares end-to-end TROP2 NMR testing across three solutions to see how closely Local and Mixed solutions align with a Reference solution in untreated advanced NSCLC. It uses an IHC assay, a digital scanner, and a QCS algorithm to generate TROP2 status, and evaluates concordance with statistics like PPA, NPA, and OPA. Stage 1 analyzes about 600 samples at a central lab; Stage 2 aims to accumulate at least 1,000 positive and 1,000 negative samples, with enrollment stopping after targets are met. The study is cross-sectional and does not include discontinuation criteria for either stage. Outcomes focus on concordance and robustness in real-world lab settings.

Why it matters

Who can join: the full rules

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.
* -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.

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.).
* 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.).

Where it's running

• Research Site
  Shanghai, Shanghai Municipality, China Recruiting
• Research Site
  Beijing, Beijing Municipality, China Not yet recruiting
• Research Site
  Guangzhou, Guangdong, China Not yet recruiting
• Research Site
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Principal investigator: zhiyong Liang — Peking Union Medical College Hospital
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.