A sing le-arm, phase I study of ramucirumab in combination with erlotinib or osimertinib in previously untreated patients with EGFR mutantion-posit ive metastatic Non-small cell lung cancer with brain metastases
Phase 1
- Conditions
- lung carcinoma, non small cellD002289
- Registration Number
- JPRN-jRCT2051190027
- Lead Sponsor
- Kaneda Hiroyasu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
The study will enroll male or female patients, 20 years of age or older. Main inclusion criteria include: metastatic NSCLC patients with asymptomatic/incidental brain metastases who are eligible for first-line treatment with erlotinib or osimertinib based on previously documented evidence of tumors that have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, ECOG PS is 0-1.
Exclusion Criteria
Key exclusion criteria include: patients with known T790M mutation; symptomatic CNS lesions; ophthalmologic abnormalities; active interstitial lung disease; and 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 Primary objective of the study is to assess the safety and tolerability of ramucirumab when administe red in combination with erlotinib or osimertinib. Safety and tolerability will be assessed based on th e DLT-evaluable population. The number of patients who experienced any DLT will be summarized.
- Secondary Outcome Measures
Name Time Method Toxicity profile<br>Objective Response Rate, ORR <br>Disease Control Rate, DCR<br>Response rate of intracranial lesions