A Phase I Study of Trametinib and Ponatinib in Patients with KRAS-Mutant Advanced Non-Small Cell Lung Cancer

Full Title

A Phase 1/2 Trial of Trametinib and Ponatinib in Patients with KRAS Mutant Advanced Non-Small Cell Lung Cancer

Purpose

The purpose of this study is to find the highest dose of the anticancer drug ponatinib that can be given safely in combination with trametinib in patients with non-small cell lung cancer (NSCLC) that contains a KRAS mutation and has continued to grow despite prior treatment that included immunotherapy and platinum drugs. Laboratory studies have shown that giving ponatinib with trametinib helps trametinib work better.

Trametinib is a drug approved for treating metastatic melanoma which works by blocking proteins called MEK1 and MEK2 and has been studied in patients with lung cancer who have KRAS mutations. Ponatinib inhibits proteins called FGFR and ABL and is used to treat chronic myelogenous leukemia. Their use together in this study is considered investigational. Both drugs are taken orally (by mouth).

Eligibility

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

  • Patients must have advanced lung adenocarcinoma that continued to grow despite prior treatment with a PD-1 inhibitor (such as nivolumab or pembrolizumab) and therapy that included platinum-containing drugs (like cisplatin).
  • Patients’ tumors must contain a KRAS mutation.
  • 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 and to inquire about eligibility for this study, please contact Dr. Gregory J. Riely at 646-888-4199.

Protocol

17-297

Phase

I/II

Investigator

Co-Investigators