- Histological or cytological diagnosis of Stage IV Non-Small Cell Lung Cancer (NSCLC)
that is either EGFR or ALK mutated.
- Untreated with/or actively treated with specific inhibitor for less than 6 months if
not progressing on active therapy.
- Age > 18.
- ECOG performance status 0, 1 or 2.
- Prior chemotherapy is allowed if > one month. Patients must not have received
chemotherapy within 4 weeks of the start of study drug.
- Brain metastases are allowed if the patient is asymptomatic or previous steroid
treatment was discontinued > 6 weeks.
- Adequate bone marrow function as defined by:
- White Blood Count (WBC) > 2.0 g/dL
- Hemoglobin > 9.0 g/dL
- Absolute neutrophil count (ANC) > 1,000/mm3
- Platelets > 100,000/mm3
- Serum bilirubin levels < 1.5 mg/dL except for patients with Gilbert's syndrome.
- Adequate organ function as defined by:
- Serum aspartate transaminase (AST) < 2.5 X upper limit of normal.
- Serum alanine transaminase (ALT) < 2.5 X upper limit of normal.
- If female and of childbearing potential, documentation of negative pregnancy test
(serum or urine) within 7 days prior to first dose.
- Able to provide informed consent and have signed an approved consent form that
conforms to federal and institutional guidelines.
- Concurrent therapy with any other non-protocol anti-cancer therapy.
- History of any other malignancy requiring active treatment.
- Patients who have had a history of acute diverticulitis, intra-abdominal abscess,
Gastrointestical obstruction and abdominal carcinomatosis which are known risk
factors for bowel perforation.
- History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic
progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of
autoimmune origin (e.g., Guillain-Barre Syndrome). History of vitiligo and adequately
controlled endocrine deficiencies such as hypothyroidism are allowed.
- Significant cardiovascular disease including:
- Active, clinically symptomatic left ventricular failure.
- Uncontrolled symptomatic hypertension that cannot be controlled with
- Myocardial infarction, severe angina, or unstable angina within 6 months prior
to administration of first dose of study drug.
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
- Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial
fibrillation that is well controlled with anti-arrhythmic medication)
- Coronary or peripheral artery bypass graft within 6 months of screening.
- Uncontrolled CNS metastases are not allowed; subjects with previously treated brain
metastases will be allowed if the brain metastases have been treated, toxicities have
resolved to grade 1 or baseline and steroids are no longer required. Leptomeningeal
metastases are not allowed.
- Serious/active infection or infection requiring parenteral antibiotics.
- Pregnant or lactating females.
- HIV infection or chronic hepatitis B or C. Negative Screening tests for HIV,
Hepatitis B, and Hepatitis C are required.
- The presence of any other medical or psychiatric disorder that, in the opinion of the
treating physician, would contraindicate the use of the drugs in this protocol or
place the subject at undue risk for treatment complications.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both