A Phase I Study of BDTX-1535 in People with Advanced Non-Small Cell Lung Cancer


Full Title

A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer


The purpose of this study is to find the highest dose of the investigational drug BDTX-1535 that can be given safely in people with inoperable or metastatic non-small cell lung cancer (NSCLC) that has mutation in the EGFR gene. Participants may also have leptomeningeal disease, which occurs when the cancer spreads to the fluid around the brain and spinal cord.

BDTX-1535 works by blocking the mutated EGFR protein, which plays a role in cancer cell growth. By blocking this protein, BDTX-1535 may help slow or stop the growth of lung cancer. It is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic NSCLC that contains an EGFR mutation.
  • The serious side effects of previous treatments must go away before receiving BDTX-1535.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information about this study and to ask about eligibility, please contact the office of Dr. Helena Yu at 646-608-3912.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID