A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
Phase 3
Completed
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222887
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria
Metastatic NSCLC patients who are eligible for first-line treatment with erlotinib (Part A and Part B) or Gefitinib (Part C) based on previously documented evidence of tumors that have EGFR exon 19 deletions or exon 21(L858R) substitution mutations.
ECOG PS of 0 or 1
Exclusion Criteria
Exclusion Criteria
Patients with known T790M mutation
Metastatic brain lesions
Ophthalmologic abnormalities
Active interstitial lung disease
Any prior systemic chemotherapy for advanced or metastatic NSCLC, including prior TKI therapy for any stage.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method