Non-small-cell lung cancer harboring a EGFR mutation
Conditions
Interventions
erlotinib (150 mg/day) plus intravenous ramucirumab (10 mg/kg) once every 2 weeks
Sponsors
North Japan Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cytologically or histologically confirmed non-small cell lung cancer harboring a EGFR activating mutation (exon 19 deletion, L858R) Clinical stage IIIB, IIIC without indication of definitive thoracic radiotherapy, stage IV, postoperative or radiotherapy recurrent disease Patients with disease progression (RECIST PD) during at least one regimen of EGFR-TKI therapy Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0-2 20 years of age or older Patients capable of oral intake and administration At least one measurable lesions (RECIST ver1.1) Patients with adequate organ function Patients expected to survive for more than 3 months Have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: Patients with symptomatic brain metastases or leptomeningeal carcinomatosis Patients with pleural effusion, ascites or pericardial effusion requiring drainage Patients with a history of EGFR-TKI-induced interstitial lung disease Patients have undergone irradiation to the chest within 2 weeks or are scheduled in the near future Patients have undergone major surgery within 28 days or are scheduled in the near future. Patients have a history of gross hemoptysis (defined as the presence of 1/2 teaspoon or more of gross blood) within 2 months prior to enrollment Patients have significant bleeding disorders, vasculitis, or experienced Grade 3/4 GI bleeding within 3 months prior to enrollment Patients have radiologically documented evidence of major blood vessel invasion or encasement by cancer Patients have radiographic evidence of intratumor cavitation Patients have tumor exposure in the central airways up to the segmental bronchus Patients have a history of GI perforation, peptic ulceration, diverticular disease, and/or fistulae within 6 months prior to enrollment Patients have experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment Patients have any evidence of clinically active interstitial lung disease Patients have uncontrolled hypertension Patients with clinically problematic coagulation disorders Patients have severe complication (uncontrolled heart failure, renal failure, chronic liver failure, diabetes mellitus, etc.) Patients with contraindications to erlotinib and ramucirumab Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy History of severe drug allergies Other ineligible status judged by attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Countries
Japan
Contacts
Public ContactYoko Tsukita
Tohoku University Graduate School of Medicine Department of Respiratory Medicine
Outcome results
None listed