NCT07613424

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable nonsmall-cell-lung-cancer

Timeline
9mo left

Started May 2026

Shorter than P25 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
May 2026Mar 2027

First Submitted

Initial submission to the registry

May 7, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 31, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 7, 2026

Last Update Submit

May 25, 2026

Conditions

Non-Small Cell Lung Cancer

Keywords

MET ConcordanceGene ProfilingNSCLS

Outcome Measures

Primary Outcomes (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).

    90 days after LPI

Secondary Outcomes (8)

  • OPA/PPA/NPA

    90 days after LPI

  • Fleiss's Kappa

    90 days after LPI

  • Treatment pattern

    90 days after LPI

  • Biomarker profiling

    90 days after LPI

  • Biomarker profiling

    90 days after LPI

  • +3 more secondary outcomes

Study Arms (3)

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.

Diagnostic Test: NGS testingDiagnostic 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.

Diagnostic Test: NGS testingDiagnostic 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.

Diagnostic Test: NGS testing

Interventions

NGS testingDIAGNOSTIC_TEST

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

cohort 1cohort 2cohort 3
MET IHC testingDIAGNOSTIC_TEST

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

cohort 1
PD-L1 and Her2 testingDIAGNOSTIC_TEST

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

cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Beijing, China

Location

Research Site

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 29, 2026

Study Start

May 31, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.
More information

Locations

CN(2)