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Report for Clinical Trial NCT02789345
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in
combination with osimertinib in participants with non-small cell lung cancer (NSCLC).
Name: Ramucirumab
Description: Administered IV
Type: Drug
Group Labels: 1 Ramucirumab + Osimertinib
Name: Necitumumab
Description: Administered IV
Type: Drug
Group Labels: 1 Necitumumab + Osimertinib
Name: Osimertinib
Description: Administered orally
Type: Drug
Group Labels: 2 Necitumumab + Osimertinib Ramucirumab + Osimertinib
Primary Outcomes
Measure: Number of Participants with Dose Limiting Toxicities (DLTs) Time: Up to Two Cycles (Up to 21 Day Cycles)
Secondary Outcomes
Measure: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab Time: Day 1 Cycle 2 to Day 1 Cycle 13 (14 Day Cycles)
Measure: PK: Cmin of Necitumumab Time: Day 1 Cycle 3 to Day 1 Cycle 9 (21 Day Cycles)
Measure: Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) Time: Baseline to Objective Disease Progression (Approximately 30 Months)
Measure: Disease Control Rate (DCR): Percentage of Participants with CR, PR or Stable Disease (SD) Time: Baseline to Objective Disease Progression (Approximately 30 Months)
Measure: Duration of Response (DoR) Time: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Approximately 30 Months)
Measure: Progression Free Survival (PFS) Time: Baseline to Measured Progressive Disease or Death from Any Cause (Approximately 30 Months)
Measure: Overall Survival (OS) Time: Baseline to Death from Any Cause (Approximately 30 Months)
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 T790M
An Open-Label, Multicenter, Phase 1 Study With Expansion Cohorts of Ramucirumab or Necitumumab in Combination With Osimertinib in Patients With Advanced T790M-Positive EGFR-Mutant Non-Small Cell Lung Cancer After Progression on First-Line EGFR TKI Therapy. --- T790M ---
- Have T790M-positive status using a test validated and performed locally after disease
progression on EGFR tyrosine kinase inhibitor (TKI) treatment. --- T790M ---