Randomized phase II study of osimertinib plus bevacizumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutations (investigator-initiated multicenter clinical trial, WJOG9717L)
- Conditions
- onsquamous non-small cell lung cancer harboring EGFR mutations untreated by chemotherapy
- Registration Number
- JPRN-UMIN000030206
- Lead Sponsor
- Coordinating committee for WJOG 9717L investigator-initiated clinical study
- Brief Summary
There was no statistically significant difference in PFS (primary endpoint) between osimertinib group and osimertinib+bevacizumab group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 122
Not provided
1)Active double cancers 2)Hemoptysis: - Bloody sputum that occurs over 1 week - Bloody sputum for which oral hemostatic drug was used continuously in the past 1 month or for which continuous use of oral hemostatic drug is required - Bloody sputum for which injectable hemostatic drug was used in the past or for which use of injectable hemostatic drug is required 3) Highly likely to have the following bleeding complications: - Bleeding tendency (coagulation disorder) - Radiologically evident of tumor invasion of thoracic great vessels, cavitation of a lung lesion or thrombus 4) Antithrombotic drug that was used in the past 10 days or will be required during the study 5) Localized infection requiring surgical intervention or active systemic infection 6) Pregnant women, lactating women, women who may be pregnant, or women not intending to prevent pregnancy 7) Clinically significant psychiatric disorder that precludes the participation in the study 8) Continuous systemic administration of steroids at prednisolone-equivalent doses of >10 mg/day is required or current use of immunosuppressive drugs 9) History of serious hypersensitivity, or hypersensitivity to component of osimertinib or bevacizumab 10) Positive serum HBs antigen 11) Following concurrent or previous conditions: - Symptomatic cerebrovascular accident - Gastrointestinal perforation, fistula, or diverticulitis - Difficult to take investigational drugs - Symptomatic congestive heart failure or unstable angina, or previous myocardial infarction within 1 year before enrollment - Mean QTc interval > 470ms, clinically severe arrhythmia, heart failure, hypokalemia , using medicine with risk of QTc prolongation or lethal arrhythmia - Evident interstitial lung disease on CT, radiation pneumonitis - Superior vena cava syndrome - Spinal cord compression - Untreated fracture or severe wound - Uncontrolled peptic ulcer - Hypertension uncontrolled by standard drug therapy (SBP >=150 mmHg or a DBP >=100 100 mmHg)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (assessed by central image reviewers)
- Secondary Outcome Measures
Name Time Method Progression-free survival (assessed by investigators), response rate, overall survival, incidence of adverse events