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.
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
51 sites in 1 country
China51 sites, 51 recruiting
- 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
- Not yet recruiting
Research Site
Tangshan, 63000
- 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
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).
- Conditions
- Non-Small Cell Lung Cancer
- 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 group | Role | What they receive |
|---|---|---|
| cohort 1 | Other | 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. Receives: Diagnostic Test: NGS testing; Diagnostic Test: MET IHC testing |
| cohort 2 | Other | 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. Receives: Diagnostic Test: NGS testing; Diagnostic Test: PD-L1 and Her2 testing |
| cohort 3 | Other | 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. Receives: Diagnostic Test: NGS testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
Biomarker profiling
Gene profiling by tissue NGS
Measured: 90 days after LPI
Biomarker profiling
•Proportion of MET OverExp in cohort 1
Measured: 90 days after LPI
Biomarker profiling
•Proportion of HER2 OverExp in cohort 2
Measured: 90 days after LPI
Biomarker profiling
•Proportion of HER2m, HER2 amp, MET exon14 in overall population
Measured: 90 days after LPI
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.
- First posted29 May 2026
- Study start2 Jun 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell 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
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study of MET Concordance and Gene Profiling in First-line Non-small Cell Lung Cancer (NSCLC) (Genomet)
- ClinicalTrials.gov ID
- NCT07613424
- Acronym / sponsor ID
- Genomet / D5162L00064
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- MET Concordance, Gene Profiling, NSCLS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 May 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.
Multicenter prospective assessment of MET concordance and tumor gene profiling in treatment-naïve NSCLC
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Other | Diagnostic Test: NGS testing, Diagnostic Test: MET IHC testingParticipants 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. |
| cohort 2 | Other | Diagnostic Test: NGS testing, Diagnostic Test: PD-L1 and Her2 testingParticipants 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. |
| cohort 3 | Other | Diagnostic Test: NGS testingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| NGS testingNGS testing first for all participants and then cohort assignment for each participant can be derived based on NGS results. | Diagnostic test | cohort 1, cohort 2, cohort 3 |
| MET IHC testingthe participants of cohort 1 need to do MET IHC testing. | Diagnostic test | cohort 1 |
| PD-L1 and Her2 testingthe participants of cohort 1 need to do PD-L1 and Her2 testing. | Diagnostic test | cohort 2 |
Primary outcome
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).
8 secondary outcomes
OPA/PPA/NPA
Time frame: 90 days after LPI
Fleiss's Kappa
Time frame: 90 days after LPI
Treatment pattern
Time frame: 90 days after LPI
Biomarker profiling
Time frame: 90 days after LPI
Biomarker profiling
Time frame: 90 days after LPI
Biomarker profiling
Time frame: 90 days after LPI
Biomarker profiling
Time frame: 90 days after LPI
Biomarker profiling
Time frame: 90 days after LPI
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 26 Oct 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
51 sites in 1 country: see every site and its status.
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.