We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02803203
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : March 3, 2022
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer EGFR-mutant Lung Cancers Drug: osimertinib Drug: Bevacizumab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Combination Osimertinib and Bevacizumab as Treatment for Patients With EGFR-mutant Lung Cancers
Actual Study Start Date : June 29, 2016
Actual Primary Completion Date : March 1, 2022
Actual Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: osimertinib and bevacizumab

Phase 1:

3+3 dose escalation design 2 dose levels Dose level -1: Osimertinib 40mg daily Maximum accrual = 12 Bevacizumab 15mg/kg q3 weeks Dose level 1: Osimertinib 80mg daily Bevacizumab 15mg/kg q3 Weeks

Phase 2:

Use MTD determined during phase 1

Drug: osimertinib
Other Name: AZD9291

Drug: Bevacizumab

Primary Outcome Measures :
  1. maximum tolerated dose (MTD) (Phase I) [ Time Frame: 1 year ]
    The MTD (maximum tolerated dose)/recommended phase 2 dose will be the highest dose level at which <1 DLT is detected in the first cycle for 6 treated patients. If only 3 patients are treated at a dose level being considered for the MTD, an additional 3 patients will be enrolled.

  2. progression-free survival (Phase II) [ Time Frame: 12 months ]
    Tumor response will be assessed using RECIST 1.1. A CT chest/abdomen/pelvis will be performed to demonstrate all known areas of measurable disease.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803203

Layout table for location information
United States, New Jersey
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Genentech, Inc.
Layout table for investigator information
Principal Investigator: Helena Yu, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02803203    
Other Study ID Numbers: 16-033
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action