A Multicenter, Prospective Study of MET Concordance and Gene Profiling in First-line Non-small Cell Lung Cancer (NSCLC) (Genomet)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 试验地点
- 2
研究概览
简要总结
Multicenter prospective assessment of MET concordance and tumor gene profiling in treatment-naïve NSCLC
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
cohort 2
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.
干预措施: PD-L1 and Her2 testing (Diagnostic Test)
cohort 3
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.
干预措施: NGS testing (Diagnostic Test)
cohort 1
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.
干预措施: NGS testing (Diagnostic Test)
cohort 1
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.
干预措施: MET IHC testing (Diagnostic Test)
cohort 2
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.
干预措施: NGS testing (Diagnostic Test)