A Phase II Study of MLN0128 to Treat Advanced Squamous Cell Lung Cancer


Full Title

A Phase 2 Study of MLN0128 (TAK-228) in Patients with Advanced Non-Small Lung Cancers Harboring NFE2L2 and KEAP-1 Mutations


MLN 0128 (sapanisertib) is an investigational drug that interferes with cancer growth by blocking two protein complexes called mTORC1 and mTORC2. Laboratory studies have shown that it can kill squamous cell lung cancer cells that contain genetic mutations in NFE2L2 or KEAP1.

In this study, researchers are assessing the safety and effectiveness of MLN0128 in patients with advanced squamous cell lung cancers that contain NFE2L2 or KEAP1 mutations. MLN0128 is 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 recurrent or metastatic squamous cell lung cancer that has a mutation in the NFE2L2 or KEAP1 gene.
  • Patients’ disease must have continued to grow despite at least one prior regimen of therapy.
  • At least 2 weeks must pass between the completion of prior chemotherapy or radiation therapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study or to inquire about eligibility, please contact Dr. Paul K. Paik at 646-888-4202.