lung carcinoma, non small cell
Conditions
Interventions
ramucirumab will be administered in combination with erlotinib or osimertinib
Sponsors
Kaneda Hiroyasu
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Toxicity profile Objective Response Rate, ORR Disease Control Rate, DCR Response rate of intracranial lesions | — |
Contacts
Public ContactChikako Minami
Osaka City University hospital
Outcome results
None listed