NCT03909334

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Xiuning Le · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Small Cell Lung Cancer
• EGFR Gene Mutation
• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	Osimertinib 80 mg orally on Day 1
DRUG	Ramucirumab	Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes for first infusion and if tolerated subsequent infusions may be over 30 minutes

Timeline

• Start date: 2019-07-25
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2019-04-10
• Last updated: 2026-04-17

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study