Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

osimertinib

Thomas Stinchcombe, MD

This is a research study to find out if a drug called, osimertinib, is safe and effective in treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal growth factor receptor (EGFR) mutation exon 18 G719X, exon 20 S7681, or exon 21 L861Q. Patients on the study will not have had previous tyrosine kinase inhibitor (TKI) treatment.

This is a research study to find out if a drug called, osimertinib, is safe and effective in treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal growth factor receptor (EGFR) mutation exon 18 G719X, exon 20 S7681, or exon 21 L861Q. Patients on the study will not have had previous tyrosine kinase inhibitor (TKI) treatment.

Patients who have one of the following EGRF mutations: exon 18 G719X, exon 20 S7681, or exon 21 L861Q) may be eligible to participate in this study. If enrolled into the study, the study team will give the patient a supply of the study drug, osimbertinib (80 mg) to take at home. The patient will be asked to take the study drug by mouth on days 1-28 of each study cycle. As part of this study, the patient will have blood samples other tests, exams and procedures done for study purposes and their standard of care. Patient participation in the study will last for up to 2 years after completion of the last dose of the study drug or until your condition worsens or intolerable adverse events as deemed by the study doctor.

There are possible patient risks to this study that include but are not limited to diarrhea, changes to the lining of the mouth (e.g. ulcers), rash, dry skin, itching, and nail infections.

A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations

A Single Arm Phase II Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations

The number of participants who have a partial response or complete response to the study drug. Complete response (CR) = Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm; partial response (PR) = ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline.

Progression will be defined as time from starting study therapy to disease progression or death (whichever occurs first).

Adverse events (regardless of attribution) observed in all enrolled participants, except for those withdrawn prior to study treatment or fail to receive study treatment for various reasons. Counts and percentages of participants who experienced any AEs are calculated.

Overall survival as defined as time from starting study therapy until death from any causes.

Duke University

Osimertinib: 80 mg oral administration daily

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants had an ECOG (Eastern Cooperative Oncology Group) score of 0 or 1. 0 = Fully active, able to carry on all pre-disease performance without restriction and 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

ECOG performance status

EGFR mutation subtype

Bone

Brain

Liver

Lung

Lymph node

Pleura

Participants could have more than one location for metastases.

Location of metastases

Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

Progression Free Survival (PFS) as Measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

Diarrhea

Fatigue

Anorexia

Weight loss

Dyspnea

Vomiting

Abdominal pain

Cough

Acneiform rash

Maculopapular Rash

Respiratory failure

Thromboembolic event

Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Overall Survival as Noted by Follow-up Via Composite of Telephone or Medical Record Review.

Overall Study

Spots Global Cancer Trial Database for exon 18 g719x