A Phase II Trial of AZD9291 (Osimertinib) With or Without Bevacizumab in Patients With EGFR Mutation Positive NSCLC and Brain Metastases

Who is this study for? Patients with EGFR mutation positive NSCLC and brain metastases
Status: Active, not recruiting
Location: See all (18) locations...
Intervention Type: Drug, Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain (brain metastases). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop or slow non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving osimertinib with or without bevacizumab may work better in treating patients with non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Non-small cell lung cancer (NSCLC) with an activating EGFR mutation (exon 19 deletion, L858R point mutation, or any other mutation known to be associated with EGFR TKI sensitivity); presence of an activating EGFR mutation may be documented in tumor tissue or by plasma testing if performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory

• No prior treatment with an EGFR TKI; patient may have received prior chemotherapy for early-stage or advanced disease but this is not required; prior immunotherapy is not allowed

• Patients must have at least one measurable CNS lesion that is asymptomatic, untreated, and does not require local therapy at the time of enrollment; measurable CNS disease is defined as a brain metastasis that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 5 mm (>= 0.5 cm) with brain magnetic resonance imaging (MRI); if the lesion is 5-10 mm in size and is the only measurable disease, MRI imaging must be performed with 1.5 mm slice thickness or less; a history of previously treated brain metastases is allowed, however any lesion present at the time of whole brain radiotherapy or included in the stereotactic radiotherapy field (or within 2 mm of the treated lesion) will NOT be considered untreated unless it is new or documented to have progressed unequivocally since treatment

• Patients are not required to have measurable systemic (i.e. non-CNS) disease; if present, measurable systemic disease must be able to be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, MRI, or calipers by clinical exam

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Life expectancy of greater than 3 months

• The use of anti-convulsants is allowed, as long as the patient is on a stable dose with no seizure activity for at least 2 weeks prior to initiating trial therapy

• Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child- bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:

• Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments

• Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution

• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation

• Fertile men should be willing to use barrier contraception during and for 4 months after AZD9291 (osimertinib), and fertile women must agree to use adequate contraceptive measures during and for 6 weeks after AZD9291 (osimertinib); fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately

• Ability to understand and the willingness to sign a written informed consent document

Locations
United States
California
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Keck Medical Center of USC Pasadena
Pasadena
University of California Davis Comprehensive Cancer Center
Sacramento
Connecticut
Smilow Cancer Center/Yale-New Haven Hospital
New Haven
Yale University
New Haven
Florida
Moffitt Cancer Center
Tampa
Moffitt Cancer Center-International Plaza
Tampa
Kansas
University of Kansas Clinical Research Center
Fairway
University of Kansas Hospital-Westwood Cancer Center
Westwood
Nebraska
Nebraska Medicine-Bellevue
Bellevue
Nebraska Medicine-Village Pointe
Omaha
University of Nebraska Medical Center
Omaha
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
Ohio
Ohio State University Comprehensive Cancer Center
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Pennsylvania
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
Time Frame
Start Date: June 23, 2017
Estimated Completion Date: July 1, 2023
Participants
Target number of participants: 112
Treatments
Experimental: Arm I (osimertinib, bevacizumab)
Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (osimertinib)
Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Authors
Jonathan W. Riess, Peter A. Forsyth, Mary R. Welch, Javier Gonzalez, Bing Xia, Vinicius Ernani, Raid Aljumaily, Jorge J. Nieva, Sarah B. Goldberg, Pierre Giglio, Liza C. Villaruz, Wallace L. Akerley, Apar K. Ganti, Kathan Mehta
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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