T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

Zhejiang University

Status: Completed

Conditions: Non-Small-Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage III

Treatments: Genetic: ctDNA analysis; Other: mutation detection; Other: ARMS and ddPCR

Study type: Observational

Funder types: Other

Identifiers

NCT02418234

HZFH CA15-02

Details and patient eligibility

About

The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

Full description

An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed stage IIIB/IV NSCLC.
• Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
• Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
• Patient must be able to comply with the protocol

Exclusion criteria

• Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
• Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
• Histologically confirmed small cell lung cancer or other metastatic tumors
• Patient with no histologic or cytological diagnosis.