Nonsquamous non-small cell lung cancer harboring EGFR mutations untreated by chemotherapy
Conditions
Interventions
Sponsors
Coordinating committee for WJOG 9717L investigator-initiated clinical study
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed nonsquamous NSCLC. 2) Confirmed EGFR mutations (exon 19 deletion, L858R) known to be associated with EGFR-TKI sensitivity with tumor tissue specimens or cytology specimens. 3) Absence of symptomatic brain metastases. Any brain metastasis with neurologic recovery by radiation therapy (corresponding to CTCAE v.4.0 grade 0 or 1) maintained for more than 2 weeks before enrollment (including the same day 2 weeks before) is acceptable. 4) Stage IIIB or IV not amenable to radical radiation therapy, or postoperative recurrence. 5) Age of 20 years or older at the time of informed consent. 6) ECOG performance status (PS) of 0 or 1 7) Presence of measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, excluding irradiated sites. 8) No prior chemotherapy for lung cancer (including EGFR-TKIs and immune checkpoint inhibitors).Any preoperative or postoperative chemotherapy given at least 6 months before enrollment in the present study is acceptable. 9) Absence of severe major organ involvement, with all of the following criteria met: - Neutrophil count =>1500/mm3 - Hemoglobin =>9.0 g/dL - Platelet count =>10.0x10,000/mm3 - PT-INR<=1.5 - AST <=100IU/L - ALT <=100IU/L - Total bilirubin <=1.5 mg/dL - Creatinine <=1.5 mg/dL - SPO2 =>90%(at room air) - Urine protein <=1+ 10) Written informed consent obtained from the patient after a sufficient explanation about the study given before enrollment in the study.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (assessed by central image reviewers) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (assessed by investigators), response rate, overall survival, incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactHirotsugu Kenmotsu
Shizuoka Cancer Center Thoracic Oncology
Outcome results
None listed