Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers

Completed · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer, EGFR-mutant Lung Cancers

In brief

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.

Key facts

Study ID

NCT02803203

Run by

Memorial Sloan Kettering Cancer Center

People needed

49

Starts

2016-06-29

Expected to finish

2022-03-01

Last updated by the study team

2023-09-22

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Hemoglobin≥8.0 g/dL
• Platelets ≥100,000/mm3

You may not qualify if…

• 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

Where it is running

• Memoral Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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