SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03909334

Developed by Shray Alag, 2019.
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 Neoplasm Metastasis
HPO: Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Osimertinib

Description: Osimertinib 80 mg orally on Day 1

Type: Drug

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

Name: Ramucirumab

Description: Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes on Day 1

Type: Drug

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

SNPs


1 L858R

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



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1