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

Plain-language summary

This study looks at the agreement between MET tests and gene profiling in non-small cell lung cancer (NSCLC) about to receive first-line treatment. It uses NGS testing, MET immunohistochemistry (IHC) testing, and PD-L1 and Her2 testing, and can include adults aged 18 or older with unresectable locally advanced (Stage IIIB/IIIC) or metastatic/recurrent (Stage IV) NSCLC who can provide a tissue sample. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

AstraZeneca

Intervention

NGS testing, MET IHC testing, PD-L1 and Her2 testing

Start date

6/2/2026

Estimated completion

3/31/2027

Countries

China

Related genes

Locations

• Beijing, China
• Shanghai, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.