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Non-Small Cell Lung CancerGenometNCT07613424

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

A study testing NGS testing, MET IHC testing and PD-L1 and Her2 testing in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 51 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

Multicenter prospective assessment of MET concordance and tumor gene profiling in treatment-naïve NSCLC Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
NGS testing, MET IHC testing and PD-L1 and Her2 testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
51 sitesChina
Study dates
2 Jun 2026to 31 Mar 2027
Phase
Interventional
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

Who may be able to join

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age
  • Participant must be ≥ 18 at the time of signing the informed consent. Type of Participant and Disease Characteristics
  • 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.
  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • Medical Conditions
  • 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.
  • 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.

Trial locations and contacts

51 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

51 sites in 1 country

China51 sites, 51 recruiting
  • Research Site

    Anyang, 455000

    Recruiting
  • Research Site

    Baoding, 071000

    Recruiting
  • Research Site

    Beijing, 100210

    Recruiting
  • Research Site

    Cangzhou, 061001

    Recruiting
  • Research Site

    Changzhi, 046000

    Recruiting
  • Research Site

    Chengdu, 610031

    Recruiting
  • Research Site

    Chengdu, 610041

    Recruiting
  • Research Site

    Fuzhou, 350005

    Recruiting
  • Research Site

    Guangzhou, 510000

    Recruiting
  • Research Site

    Guangzhou, 510120

    Recruiting
  • Research Site

    Guangzhou, 510515

    Recruiting
  • Research Site

    Handan, 130403

    Recruiting
  • Research Site

    Hefei, 133500

    Recruiting
  • Research Site

    Huzhou, 313003

    Recruiting
  • Research Site

    Jinan, 250011

    Recruiting
  • Research Site

    Jinan, 250021

    Recruiting
  • Research Site

    Jining, 272011

    Recruiting
  • Research Site

    Linhai, 317000

    Recruiting
  • Research Site

    Linyi, CN-276003

    Recruiting
  • Research Site

    Lishui, 323000

    Recruiting
  • Research Site

    Liuzhou, 545006

    Recruiting
  • Research Site

    Nanchang, 330000

    Recruiting
  • Research Site

    Nanjing, 210000

    Recruiting
  • Research Site

    Nanning, 530021

    Recruiting
  • Research Site

    Nantong, 226001

    Recruiting
  • Research Site

    Qiqihar, 161005

    Recruiting
  • Research Site

    Shanghai, 200080

    Recruiting
  • Research Site

    Shanghai, 200433

    Recruiting
  • Research Site

    Shaoxing, 312000

    Recruiting
  • Research Site

    Shenyang, 110042

    Recruiting
  • Research Site

    Shenzhen, 518039

    Recruiting
  • Research Site

    Shijiazhuang, 50051

    Recruiting
  • Research Site

    Shiyan, 442000

    Recruiting
  • Research Site

    Suining, 629000

    Recruiting
  • Research Site

    Taiyuan, 030000

    Recruiting
  • Research Site

    Taiyuan, 030032

    Recruiting
  • Research Site

    Tangshan, 63000

    Not yet recruiting
  • Research Site

    Tianjin, 300192

    Recruiting
  • Research Site

    Tianjin, 300222

    Recruiting
  • Research Site

    Weifang, 261000

    Recruiting
  • Research Site

    Wenzhou, 325000

    Recruiting
  • Research Site

    Wuhan, 430000

    Recruiting
  • Research Site

    Wuhan, 430030

    Recruiting
  • Research Site

    Wuhu, 241000

    Recruiting
  • Research Site

    Wuhu, 241004

    Recruiting
  • Research Site

    Xi'an, 710114

    Recruiting
  • Research Site

    Xiamen, 361004

    Recruiting
  • Research Site

    Xiangyang, 441000

    Recruiting
  • Research Site

    Yangzhou, 225001

    Recruiting
  • Research Site

    Zhoushan, 316000

    Recruiting
  • Research Site

    Zunyi, 563100

    Recruiting

Other trials in China

About this study

Official title: 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

Read the 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).

Being tested
NGS testing, MET IHC testing, PD-L1 and Her2 testing
Keywords
MET Concordance, Gene Profiling, NSCLS
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • NGS testingDiagnostic test

    NGS testing first for all participants and then cohort assignment for each participant can be derived based on NGS results.

  • MET IHC testingDiagnostic test

    the participants of cohort 1 need to do MET IHC testing.

  • PD-L1 and Her2 testingDiagnostic test

    the participants of cohort 1 need to do PD-L1 and Her2 testing.

Study groups in NCT07613424
Study groupRoleWhat they receive
cohort 1OtherParticipants 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.
Receives: Diagnostic Test: NGS testing; Diagnostic Test: MET IHC testing
cohort 2OtherParticipants 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.
Receives: Diagnostic Test: NGS testing; Diagnostic Test: PD-L1 and Her2 testing
cohort 3OtherParticipants 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.
Receives: Diagnostic Test: NGS testing

What is being measured

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

  1. OPA/PPA/NPA

    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).

    Measured: 90 days after LPI

Secondary outcomes (8)
  1. OPA/PPA/NPA

    The testing concordance between central lab and local labs using Amoy D1C2 assay will be evaluated by the metrisc including OPA/PPA/NPA.

    Measured: 90 days after LPI

  2. Fleiss's Kappa

    Fleiss's Kappa will be calculated to assess the inter-rater agreement of MET IHC interpretation made by 20 pathologists.

    Measured: 90 days after LPI

  3. Treatment pattern

    The number and percentage of participants in cohort 1 and cohort 2 using different treatment patterns will be summarized.

    Measured: 90 days after LPI

  4. Biomarker profiling

    Gene profiling by tissue NGS

    Measured: 90 days after LPI

  5. Biomarker profiling

    •Proportion of MET OverExp in cohort 1

    Measured: 90 days after LPI

  6. Biomarker profiling

    •Proportion of HER2 OverExp in cohort 2

    Measured: 90 days after LPI

  7. Biomarker profiling

    •Proportion of HER2m, HER2 amp, MET exon14 in overall population

    Measured: 90 days after LPI

  8. Biomarker profiling

    •Proportion of HER2 OverExp \& PD-L1+ in cohort 2

    Measured: 90 days after LPI

Timeline

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

  1. First posted29 May 2026
  2. Study start2 Jun 2026
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07613424
Sponsor's protocol ID
D5162L00064
Acronym
Genomet
Status last verified
Oct 2026
First submitted
7 May 2026
Last updated
26 Oct 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.

Questions about this trial

What is this clinical trial studying?

A study testing NGS testing, MET IHC testing and PD-L1 and Her2 testing in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 51 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 9 inclusion and 3 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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?

OPA/PPA/NPA (time frame: 90 days after LPI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Oct 2026.

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