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Report for Clinical Trial NCT02789345

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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).

NCT02789345 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

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 ---



HPO Nodes


HPO: