Lung Cancer Clinical Trial
Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers
The purpose of this study is to test the safety of combining the drugs osimertinib and bevacizumab at different dose levels. The investigators want to find out what effects, good and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This study will try to find the best dose of osimertinib and bevacizumab given together that does not cause significant side effects. Once the investigators determine that combining osimertinib and bevacizumab is safe, they want to see if the combination is effective in treating lung cancers with the EGFR mutation.
Written informed consent
Advanced biopsy-proven metastatic non-small cell lung cancer
Somatic activating mutation in EGFR
No prior treatment with an EGFR TKI
No prior treatment with a VEGF inhibitor
Measurable (RECIST 1.1) indicator lesion not previously irradiated
Karnofsky performance status (KPS) ≥ 70%
Age >18 years old
Adequate organ function
AST, ALT ≤ 3 x ULN
Total bilirubin ≤ 1.5x ULN
Creatinine ≤ 1.5x ULN OR calculated creatinine clearance > 60ml/min
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
Any contra-indications to bevacizumab which include but are not limited to recent
Any previous venous thromboembolism > NCI CTCAE Grade 3
Severe uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥ 100mmHg)
Cardiovascular disease including stroke of myocardial infarction <6 months prior to study enrollment, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrythmia uncontrolled by medication
Hemorrhagic brain metastases. Asymptomatic (not requiring escalating doses of steroids) brain metastases are acceptable.
History of severe proteinuria (urine dipstick ≥ 2+ or 24 hr urine > 2gm/24hr)
Prior history of hypertensive crisis or hypertensive encephalopathy
History of a central nervous system disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy
Significant vascular disease (e.g. aortic aneurysm requiring surgical repair)≥ 6 months prior to study enrollment
History of hemoptysis (≥1/2 teaspoon of bright red blood per episode) within the last 3 months
Evidence of a bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Current or recent (within 10 days of study drug start) use of aspirin (>325mg daily), clopidogrel (>75mg daily).
Recent initiation of full dose oral or parental anticoagulants that have not been in place for at least 2 weeks.
Tumor invading or abutting major blood vessels
Tumor histology classified by squamous cell histology.
Any history of abdominal fistula or GI perforation within 6 months of study enrollment
Pregnant or lactating women
Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol
Any radiotherapy within 1 week of starting treatment on protocol
Any major surgery within 4 weeks of starting treatment on protocol
Any evidence of clinically significant interstitial lung disease
Known hypersensitivity to any component of bevacizumab and osimertinib
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There are 6 Locations for this study
Basking Ridge New Jersey, , United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
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