A Study of MET Concordance and Gene Profiling in 1L NSCLC (Genomet) (Genomet)

July 13, 2026 updated by: AstraZeneca

A Multicenter, Prospective Study of MET Concordance and Gene Profiling in First-line Non-small Cell Lung Cancer (NSCLC) (Genomet)

Multicenter prospective assessment of MET concordance and tumor gene profiling in treatment-naïve NSCLC

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to evaluate the agreement among four different test methods with a reference assay for MET OverExp. Analyses for primary endpoints will be conducted in assays concordance analysis set (ACS).

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Research Site
      • Shanghai, China
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

  1. Participant must be ≥ 18 at the time of signing the informed consent. Type of Participant and Disease Characteristics
  2. Participants who are in accordance with the Eighth Edition of TNM Staging of Lung Cancer by the International Association for the Study of Lung Cancer and American Joint Committee on Cancer, histologically or cytologically confirmed unresectable locally advanced (Stage ⅢB/ⅢC), metastatic or recurrent (Stage IV) NSCLC.
  3. Willing to provide adequate tissue sample:

1Biopsy tissue must be collected after confirmation of unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) NSCLC diagnosis, and before initiation of any antitumor therapy. The biopsy specimens require at least 16 FFPE slides.

or 2Surgical specimens only for patients with recurrent disease who either received no adjuvant therapy, or received only adjuvant chemotherapy and recurrence occurred >6 months after completing chemotherapy. The surgical specimens require at least 13 FFPE slides (surgical specimens obtained within 2 years before ICF signing).

Informed Consent 4.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

5.Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses.

Exclusion Criteria:

Medical Conditions

  1. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have a small possibility of recurrence. Participants with radically treated carcinoma in situ (non-infiltrating), papillary thyroid carcinoma and skin cancer other than malignant melanoma can be enrolled.
  2. Prior radiotherapy or systemic therapy for unresectable locally advanced (Stage IIIB/IIIC) or metastatic/recurrent (Stage IV) NSCLC, except patients initiating first-line therapy for this specific disease stage within 1 month before ICF signing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: cohort 1
Participants will be assigned to study cohorts based on the EGFR mutation status determined by central NGS testing. Only participants with EGFR mutations (EGFR 19del+/L858R+) will be included in Cohort 1.
Diagnostic test: NGS testing
NGS testing first for all participants and then cohort assignment for each participant can be derived based on NGS results.
Diagnostic test: MET IHC testing
the participants of cohort 1 need to do MET IHC testing.
Other: cohort 2
Participants will be assigned to study cohorts based on the EGFR mutation status determined by central NGS testing.Those with no actionable genomic alterations (non-AGA), defined as EGFR 19del-/L858R-/20ins-/PACC-, ALK-, ROS1-, BRAF V600-, NTRK-, KRAS G12C-, MET amp-, MET exon14-, and RET-, will be assigned to Cohort 2.
Diagnostic test: NGS testing
NGS testing first for all participants and then cohort assignment for each participant can be derived based on NGS results.
Diagnostic test: PD-L1 and Her2 testing
the participants of cohort 1 need to do PD-L1 and Her2 testing.
Other: cohort 3
Participants will be assigned to study cohorts based on the EGFR mutation status determined by central NGS testing.Those with other actionable genomic alterations (AGA, excluding EGFR 19del+/L858R+), defined as EGFR 20ins+, EGFR PACC+, ALK+, ROS1+, BRAF V600+, NTRK+, KRAS G12C+, MET amp+, MET exon14+, or RET+, will be assigned to Cohort 3.
Diagnostic test: NGS testing
NGS testing first for all participants and then cohort assignment for each participant can be derived based on NGS results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OPA/PPA/NPA
Time Frame: 90 days after LPI
The primary objective is to evaluate the agreement among four different test methods with a reference assy for MET OverExpression. Key agreement metrics includes Overall Percent Agreement (OPA),Positive percent agreement (PPA),Negative percent agreement (NPA).
90 days after LPI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OPA/PPA/NPA
Time Frame: 90 days after LPI
The testing concordance between central lab and local labs using Amoy D1C2 assay will be evaluated by the metrisc including OPA/PPA/NPA.
90 days after LPI
Fleiss's Kappa
Time Frame: 90 days after LPI
Fleiss's Kappa will be calculated to assess the inter-rater agreement of MET IHC interpretation made by 20 pathologists.
90 days after LPI
Treatment pattern
Time Frame: 90 days after LPI
The number and percentage of participants in cohort 1 and cohort 2 using different treatment patterns will be summarized.
90 days after LPI
Biomarker profiling
Time Frame: 90 days after LPI
Gene profiling by tissue NGS
90 days after LPI
Biomarker profiling
Time Frame: 90 days after LPI
•Proportion of MET OverExp in cohort 1
90 days after LPI
Biomarker profiling
Time Frame: 90 days after LPI
•Proportion of HER2 OverExp in cohort 2
90 days after LPI
Biomarker profiling
Time Frame: 90 days after LPI
•Proportion of HER2m, HER2 amp, MET exon14 in overall population
90 days after LPI
Biomarker profiling
Time Frame: 90 days after LPI
•Proportion of HER2 OverExp & PD-L1+ in cohort 2
90 days after LPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5162L00064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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