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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 22, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Drug: osimertinib; Drug: Bevacizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- Any contra-indications to bevacizumab which include but are not limited to recent 1. Any previous venous thromboembolism \> NCI CTCAE Grade 3 2. Severe uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥ 100mmHg) 3. 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 4. Hemorrhagic brain metastases. Asymptomatic (not requiring escalating doses of steroids) brain metastases are acceptable. 5. History of severe proteinuria (urine dipstick ≥ 2+ or 24 hr urine \> 2gm/24hr) 6. Prior history of hypertensive crisis or hypertensive encephalopathy 7. History of a central nervous system disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy 8. Significant vascular disease (e.g. aortic aneurysm requiring surgical repair)≥ 6 months prior to study enrollment 9. History of hemoptysis (≥1/2 teaspoon of bright red blood per episode) within the last 3 months 10. Evidence of a bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) 11. Current or recent (within 10 days of study drug start) use of aspirin (\>325mg daily), clopidogrel (\>75mg daily). 12. Recent initiation of full dose oral or parental anticoagulants that have not been in place for at least 2 weeks. 13. Tumor invading or abutting major blood vessels 14. Tumor histology classified by squamous cell histology. 15. 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memoral Sloan Kettering Basking RidgeBasking Ridge, New Jersey
- Memorial Sloan Kettering MonmouthMiddletown, New Jersey
- Memorial Sloan Kettering BergenMontvale, New Jersey
- Memorial Sloan Kettering commackCommack, New York
- Memorial Sloan Kettering WestchesterHarrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Memorial Sloan Kettering NassauUniondale, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 22, 2023. Always confirm current availability with the study team.