This research study is studying a combination of two targeted therapies as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The drugs involved in this study are: - Osimertinib (Tagrisso) - Selumetinib
Name: Osimertinib
Description: may stop (or "inhibit") the growth of a cancer with a mutation in the EGFR geneType: DrugOsimertinib + Selumetinib
Name: Selumetinib
Description: may enhance the effect of osimertinib to stop (or "inhibit") the growth of a cancer with a mutation in the EGFR geneType: DrugOsimertinib + Selumetinib
Description: RECIST1.1 measurements of CT scans will be measured during treatment to determine the objective response rate for patients being treated with combination osimertinib and selumetinib. A response rate and a 95% confidence interval will be calculated.
Measure: Best Objective Response Time: 2 yearsDescription: Time from registration to documented disease progression or death from any cause, whichever occurs first. The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination osimertinib and selumetinib.
Measure: Progression Free Survival Time: 2 yearsDescription: Survival follow-up with clinic visits or phone calls will be used to monitor for overall survival, from the time of study randomization to death from any cause. The Kaplan-Meier method will be used to calculate overall survival.
Measure: Overall Survival Time: 2 yearsDescription: Fraction of patients continuing on study therapy at 6 months.
Measure: Tolerability Time: 2 yearsDescription: Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.
Measure: Toxicity Time: 2 yearsSingle Group Assignment
There are 2 SNPs
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.. Inclusion Criteria: - Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) from time of diagnosis with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. --- L858R ---
Inclusion Criteria: - Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) from time of diagnosis with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. --- L858R ---
- left ventricular ejection fraction of < 45% - Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol - Known to be T790M+ (on pre-treatment tumor or plasma) or known germline T790M. --- T790M ---