SNPMiner Trials by Shray Alag

SNPMiner SNPMiner Trials (Home Page)

Report for Clinical Trial NCT03909334

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-naïve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.

NCT03909334 Non Small Cell Lung Cancer EGFR Gene Mutation Advanced Cancer Metastatic Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Osimertinib

Description: Osimertinib 80 mg orally on Day 1
Type: Drug
Group Labels: 2

Arm A (Osimertinib and Ramucirumab) Arm B (Osimertinib)

Name: Ramucirumab

Description: Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes for first infusion and if tolerated subsequent infusions may be over 30 minutes
Type: Drug
Group Labels: 1

Arm A (Osimertinib and Ramucirumab)

Primary Outcomes

Description: Progression free survival (PFS) time will be calculated from the date of randomization to disease progression or death from any cause, whichever occurs the first.

Measure: Progression Free Survival (PFS)

Time: 3 years

Secondary Outcomes

Description: Objective Response Rate (ORR) is defined as the number (%) of subjects with measurable disease with at least one visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of ORR.

Measure: Objective Response Rate (ORR)

Time: 1 year

Description: Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of CR or PR or stable disease (SD).

Measure: Disease control rate (DCR)

Time: 2 years

Description: Overall survival (OS) time is defined from the date of randomization to death date. A patient is censored at the last follow-up date if death has not been observed.

Measure: Overall survival (OS)

Time: 3 years

Description: Toxicities will be measured in frequency and severity using CTCAE v5

Measure: Assess frequency and severity of adverse events

Time: 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 L858R

- NSCLC which harbors EGFR L858R mutation. --- L858R ---

HPO Nodes