Clinical study of apatinib combined with EGFR-TKI in the treatment of chronic progression after EGFR-TKI treatment in non-small cell lung cancer (ChiCTR1800019185)

Thorac Cancer. 2020 Mar;11(3):819-826. doi: 10.1111/1759-7714.13303. Epub 2020 Jan 9.

Abstract

This clinical trial (ChiCTR1800019185) is designed to be an open-label, prospective, single-center, single arm exploratory research study. The study will recruit non-small cell lung cancer patients (NSCLC) with slow progression after first-line treatment with EGFR-TKI drugs. Slow progression will be confirmed by the presence of serum carcinoembryonic antigen or imaging evaluation. The primary aim is to assess progression-free survival after EGFR-TKIs treatment combined with apatinib 250 mg once daily. The secondary objectives are to evaluate objective efficacy, disease control rates, quality of life, overall survival, and safety. From September 2018 to September 2020, under specific entry and discharge standards, we plan to enroll 38 eligible patients until the end of the study. We hope that our study will help to explore a new way of combining the small molecular inhibitors of antiangiogenesis with EGFR-TKIs to overcome acquired drug resistance.

Keywords: Apatinib; EGFR-TKIs; non-small cell lung cancer; slow progression.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / genetics
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Crown Ethers / administration & dosage
  • Disease Progression
  • Drug Resistance, Neoplasm*
  • ErbB Receptors / genetics
  • Erlotinib Hydrochloride / administration & dosage
  • Female
  • Follow-Up Studies
  • Gefitinib / administration & dosage
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / genetics
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Mutation*
  • Prognosis
  • Prospective Studies
  • Pyridines / administration & dosage
  • Quinazolines / administration & dosage
  • Research Design
  • Young Adult

Substances

  • Crown Ethers
  • Pyridines
  • Quinazolines
  • apatinib
  • icotinib
  • Erlotinib Hydrochloride
  • EGFR protein, human
  • ErbB Receptors
  • Gefitinib