At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 135 enrolled
Drug / intervention
Lenvatinib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Histologically or cytologically confirmed non-squamous NSCLC with locally advanced or metastatic disease
- ✓Failed at least two lines of systemic anticancer therapy for advanced or metastatic NSCLC
- ✓EGFR-activating mutations: must have received erlotinib or gefitinib prior to entry if EGFR mutation known and drug available in country
- ✓ALK-positive disease: must have received crizotinib prior to entry if drug available in country
Key exclusion· 9
- ✕Prior therapy with E7080 or other VEGF inhibitors
- ✕Presence of brain metastases unless adequately treated, stable, asymptomatic, and off steroids for ≥4 weeks prior to randomization
- ✕Meningeal carcinomatosis
- ✕Prior chemotherapy, targeted therapy, radiotherapy, surgery, or immunotherapy within 21 days or unrecovered Grade >2 toxicity (except alopecia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) Versus BSC Alone in Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens
In Brief
A Phase 2 clinical trial evaluating Lenvatinib, Lenvatinib matched placebo, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 135 participants across 50 sites in 7 countries.
Detailed Summary
The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesBelgium, Czechia, Hungary, Italy, South Korea, United Kingdom, United States
CollaboratorsQuintiles, Inc.
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedFeb 2012
Primary CompletionJan 2014
Study CompletionJun 2015
TodayJul 2026
First PostedFeb 8, 2012
Enrollment StartNov 1, 2011
Primary CompletionJan 21, 2014
Study CompletionJun 27, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.4 years ago
Interventions
Lenvatinibdrug
Lenvatinib matched placebodrug
BSCdrug