Clinical trial · Interventional
A Study of MET Concordance and Gene Profiling in 1L NSCLC (Genomet)
A Multicenter, Prospective Study of MET Concordance and Gene Profiling in First-line Non-small Cell Lung Cancer (NSCLC) (Genomet)
NCT07613424CI-TRIAL-00117832GenometrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter prospective assessment of MET concordance and tumor gene profiling in treatment-naïve NSCLC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MET IHC testing | Diagnostic Test | — | UNRESOLVED |
| NGS testing | Diagnostic Test | — | UNRESOLVED |
| PD-L1 and Her2 testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- cohort 1
- description
- 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.
- interventionNames
- Diagnostic Test: NGS testing
- Diagnostic Test: MET IHC testing
- type
- OTHER
- label
- cohort 2
- description
- 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.
- interventionNames
- Diagnostic Test: NGS testing
- Diagnostic Test: PD-L1 and Her2 testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.