142TiP - A prospective multi-center study to investigate the EGFR-TKI resistance profile, treatment algorithm and clinical outcome in Chinese patients with...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Thoracic Malignancies
Non-Small Cell Lung Cancer
Presenter Wenhua Liang
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors W. Liang1, L. Wu2, L. Wang3, Y. Huang4, R. Xu5, L. Zhang6, J. He7
  • 1Thoracic Oncology, The 1st Affiliated Hospital of Guangzhou Medical University, 510120 - Guangzhou/CN
  • 2Hunan Province Tumor Hospital, Changsha/CN
  • 3Hainan General Hospital, Hainan/CN
  • 4Yunnan Tumour Hospital (3rd Affiliated Hospital Affiliated to Kunming Medical College), Kunming/CN
  • 5Shenzhen People’s Hospital, Shenzhen/CN
  • 6Cancer Centre Sun Yat-Sen University, Guangzhou/CN
  • 7Department Of Thoracic Surgery/oncology, The 1st Affiliated Hospital of Guangzhou Medical University, Guangzhou/CN

Abstract

Background

The resistance mechanism is impactful to make treatment strategy after prior first generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) failure and the profile has well established in western population; while without solid data among Asian population. In addition, methods used in determining previously reported resistance profiles are flawed in failing to detect concomitant or heterogeneous mechanisms. High throughput next-generation sequencing (NGS), which allows parallel multiplex genotyping with tissue or plasma sample, can help in addressing these issues. Furthermore, little was known about the treatment algorithms and clinical outcomes of different mechanisms in China. Thus, the study aims to investigate the resistance mechanism, treatment strategy and clinical outcome for those patients with prior EGFR-TKI in China.

Trial design

We are going to perform a prospective, multi-center study to obtain: a) the biomarker profile of EGFR-TKI acquired resistance detected based on paired tissue and blood respectively; b) concordance of T790M detection by NGS in blood sample with that in tissue sample as reference; c) the clinical outcomes (ORR, DCR, PFS of subsequent treatment and OS) of patients with different resistance mechanisms by NGS in tissue samples and blood samples. All the paired re-biopsy tissue and blood samples will be collected and subjected to NGS panel testing by central lab. Treatment strategy will be summarized and described. The assessment will be performed every 6 weeks until objective disease progression as defined by RECIST1.1. Survival follow-up will be conducted every 6 weeks until death, lost to follow-up, withdrawal of consent or the DCO (data cut off). A sample size of 100 patients will provide 80% power to detect at least 1 case of resistance mechanism with a proportion of 1.5% and a precision of 9% for an assumed concordance 70% of T790M mutation between tissue and blood samples. First subject will be enrolled in Feb 2017.

Clinical trial identification

NCT02988141

Legal entity responsible for the study

Guangdong Association of Thoracic Disease (China)

Funding

AstraZeneca

Disclosure

L. Zhang: Member on an advisory board and receives lecture fees from AstraZeneca. All other authors have declared no conflicts of interest.