Non-Small Cell Lung Cancer
Conditions
Keywords
MET Concordance, Gene Profiling, NSCLS
Brief summary
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).
Interventions
DIAGNOSTIC_TESTNGS testing
NGS testing first for all participants and then cohort assignment for each participant can be derived based on NGS results.
DIAGNOSTIC_TESTMET IHC testing
the participants of cohort 1 need to do MET IHC testing.
DIAGNOSTIC_TESTPD-L1 and Her2 testing
the participants of cohort 1 need to do PD-L1 and Her2 testing.
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OPA/PPA/NPA | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OPA/PPA/NPA | 90 days after LPI | The testing concordance between central lab and local labs using Amoy D1C2 assay will be evaluated by the metrisc including OPA/PPA/NPA. |
| Fleiss's Kappa | 90 days after LPI | Fleiss's Kappa will be calculated to assess the inter-rater agreement of MET IHC interpretation made by 20 pathologists. |
| Treatment pattern | 90 days after LPI | The number and percentage of participants in cohort 1 and cohort 2 using different treatment patterns will be summarized. |
| Biomarker profiling | 90 days after LPI | Gene profiling by tissue NGS |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed