Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer Read More

Inclusion Criteria:

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)
• Histologically or cytologically confirmed, treatment-naive (or status post a single treatment regimen of a tyrosine kinase inhibitor as a single agent) stage IV non-squamous, NSCLC
• Measurable disease according to modified RECIST version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Expected survival time of >= 3 months in the opinion of the investigator
• Postmenopausal women; women are eligible if they are postmenopausal (older than 50 years of age with no spontaneous menses for at least 12 months; or 50 years of age or younger either with no spontaneous menses [amenorrheic] within 12 months of randomization [e.g., spontaneous or secondary to hysterectomy] and a follicle-stimulating hormone level within the postmenopausal range or with prior bilateral oophorectomy)
• Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening

Exclusion Criteria:

• History of another primary cancer within 3 years prior to day 1 with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ
• Untreated central nervous system (CNS) involvement; (treated CNS involvement is permitted only if the patient is not currently on steroid therapy or has remained on a stable, unchanged dose of steroid for >= 3 weeks)
• Recent major surgery within the prior 4 weeks; (mediastinoscopy or placement of a central venous access will be allowed as long as placement was more than 7 days prior to receiving study drug)
• Any prior or concurrent investigational or standard therapy for treatment of metastatic NSCLC including radiation therapy, chemotherapy, biological therapy (with the exception of a single treatment regimen of a tyrosine kinase inhibitor as a single agent, which must be completed 28 days prior to day 1), hormonal therapy, or immunotherapy; (palliative-targeted radiotherapy for brain or bone metastases is permitted providing it has been at least 14 days prior to day 1)
• History of hormone replacement therapy (estrogens with or without progestin) or an aromatase inhibitor (anastrazole, letrozole, exemestane) within 8 weeks prior to day 1
• Osteoporosis complicated by pathologic fracture
• Concurrent investigational agents for non-malignant disease or prior investigational agents for non-malignant disease within 4 weeks or 5 half-lives (whichever is shorter) prior to day 1
• Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
• Absolute neutrophil count (ANC) < 1500/mL
• Platelet count < 100,000/mL
• Hemoglobin < 9.0 g/dL
• Serum bilirubin > 1.5 x upper limits of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x ULN (AST and ALT > 5 x ULN for subjects with liver metastasis)
• Glomerular filtration rate (GFR) =< 50
• Albumin =< 2.5 g/dL
• Known history of or positive test result for human immunodeficiency virus (HIV)
• Active infection (including HIV/acquired immune deficiency syndrome [AIDS], hepatitis B, or hepatitis C infection) requiring systemic antibiotics, antivirals, or antifungals
• History of myocardial infarction within 12 months prior to day 1 or clinically significant coronary disease
• New York Heart Association grade II or greater congestive heart failure
• Unstable coronary disease or clinically significant electrocardiogram (ECG) (12-lead) abnormalities, as determined by the investigator
• Inability to comply with study and follow-up procedures
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
• Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment