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Report for Clinical Trial NCT03392246

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

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

NCT03392246 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Osimertinib

Description: may stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
Type: Drug
Group Labels: 1

Osimertinib + 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 gene
Type: Drug
Group Labels: 1

Osimertinib + Selumetinib


Primary Outcomes

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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: Fraction of patients continuing on study therapy at 6 months.

Measure: Tolerability

Time: 2 years

Description: Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.

Measure: Toxicity

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

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) 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) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. --- L858R ---


2 T790M

- Baseline left ventricular ejection fraction (LVEF) below the LLN or of < 45% measured by echocardiography/MUGA; atrial fibrillation with a ventricular rate > 100 bpm on ECG at rest. - 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 ---



HPO Nodes


HPO: