A Phase II Study of Alectinib, Entrectinib, or Vemurafenib/Cobimetinib Therapy Before Surgery in Patients with Nonmetastatic Non-Small Cell Lung Cancer with Certain Molecular Changes

Full Title

NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IB-III NONSMALL CELL LUNG CANCER

Purpose

The purpose of this study is to compare the safety and effectiveness of personalized drug treatments that are given before surgery to remove stage I, II, or III non-small cell lung cancer (NSCLC) in patients whose tumors have certain genetic changes (mutations). Researchers believe these targeted therapies may effectively treat the tumor before surgery.

Patients will be assigned to a study treatment depending on which genetic mutation they have:

• Patients with ALK gene mutations will receive the drug alectinib before surgery
• Those with ROS1 or NTRK gene mutations will receive entrectinib before surgery
• Patients with BRAF gene mutations will receive vemurafenib and cobimetinib before surgery

If patients show they are benefiting from the study treatment, they may continue to take it after surgery plus any additional lung cancer therapies the doctor thinks are necessary. Each of these medications is approved for use in patients with metastatic NSCLC; however, the use of these treatments before surgery in patients with nonmetastatic NSCLC is considered investigational. All of these medications are taken orally (by mouth).

Who Can Join

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

• Patients must have stage I, II, or III NSCLC that has not been previously treated and is able to be surgically removed.
• Patients’ tumors must have a specific mutation in one of these genes: ALK, ROS1, NTRK, or BRAF.
• 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 about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-608-3761.