A Phase I Study of DS-1205c and Osimertinib for Patients with EGFR-Mutant Non-Small Cell Lung Cancer

Full Title

DS1205-A-U101: A Multicenter, Open-Label Phase 1 Study of DS-1205c in Combination with Osimertinib in Subjects with Metastatic or Unresectable EGFR-Mutant Non-Small Cell Lung Cancer


Most non-small cell lung cancers (NSCLC) with mutations in EGFR, the epidermal growth factor receptor, are treated with EGFR-targeting drugs (such as erlotinib, afatinib, or gefitinib), but the cancers eventually progress. In many patients, the resistance to EGFR inhibitors is due to a mutation called EGFR T790M, and those patients may receive another drug called osimertinib.

Patients whose cancer progresses after erlotinib, afatinib, or gefitinib and who do not have an EGFR T790M mutation, however, have no further approved targeted therapy options. In this study, researchers want to find the highest dose of the investigational drug DS-1205c that can be given safely with osimertinib in patients with advanced NSCLC that is EGFR-mutant but does not contain the T790M mutation.

DS-1205c is designed to block the activity of a protein called AXL. AXL is one of a number of important proteins that are thought to cause resistance to EGFR inhibitors. Combining DS-1205c with an EGFR inhibitor like osimertinib may overcome this resistance. Both drugs are taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic NSCLC that has continued to grow despite treatment with erlotinib, gefitinib, or afatinib and does not contain the T790M mutation.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.