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Report for Clinical Trial NCT02789345
Developed by Shray Alag, 2020-2021.
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 ---