Clinical trial NCT00693992 (phase 3, status: completed)
Conditions: stage iiib lung non-small cell cancer ajcc v7, stage iv non-small cell lung cancer ajcc v7
ICD codes: C96.20, C96.29, D47.09, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic documentation of primary non-small cell lung cancer

          -  Stage IIIB or IV disease patients who are not candidates for combined modality therapy
             (chemoradiotherapy)

          -  No evidence of symptomatic or untreated brain metastases, spinal cord compression, or
             carcinomatous meningitis; patients with central nervous system (CNS) metastases must
             be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or
             >= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a
             stable dose for 2 weeks prior to registration

          -  No cavitary lesions

          -  Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the
             regimen must include four cycles of platinum-based doublet chemotherapy with or
             without bevacizumab (bevacizumab may not be given beyond the fourth cycle of
             chemotherapy); patients must have achieved a complete response, partial response, or
             stable disease to first-line chemotherapy and have no evidence of disease progression;
             patients will be registered 3-5 weeks following day 1 of cycle 4 of prior therapy

          -  No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality
             therapy for stage III NSCLC

          -  No other primary therapy (including experimental therapy) for NSCLC; palliative
             radiation therapy must have been completed at least one week before planned start of
             protocol therapy

          -  Patients must have measurable or non-measurable disease

               -  Measurable disease: lesions that can be accurately measured in at least one
                  dimension (longest diameter to be recorded) as >= 2 cm with conventional
                  techniques or as >= 1 cm with spiral computed tomography (CT) scan

               -  Non-measurable disease: all other lesions, including small lesions (longest
                  diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and
                  truly non-measurable lesions; lesions that are considered non-measurable include
                  the following:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

                    -  Abdominal masses that are not confirmed and followed by imaging techniques

                    -  Cystic lesions

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Non-pregnant and non-nursing

          -  No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc)
             interval >= 500 msec (within 2 years prior to registration); the use of agents with
             proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol,
             probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while
             on protocol therapy

          -  Patients with class I New York Heart Association (NYHA) heart failure are eligible;
             patients with a history of class II NYHA heart failure are eligible, provided they
             meet at least one of the following criteria:

               -  Patients with a history of class II heart failure who are asymptomatic on
                  treatment

               -  Patients with prior anthracycline exposure

               -  Patients who have received central thoracic radiation that included the heart in
                  the radiotherapy port

          -  Patients with a history of class III or IV NYHA heart failure within 12 months prior
             to registration are not eligible

          -  No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft or stenting, cerebrovascular accident or transient ischemic attack within the
             last year

          -  Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg
             despite optimal medical therapy) are not eligible

          -  Patients who require use of therapeutic anticoagulation for thromboembolic disease are
             not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for
             prophylaxis of thrombosis

          -  No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome

          -  No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis;
             patients with blood-tinged or blood-streaked sputum will be permitted on study if the
             hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of blood
             per 24-hour period in the best estimate of the investigator

          -  Patients with a history of hypothyroidism are eligible, provided they are currently
             euthyroid

          -  None of the following within 28 days of beginning treatment: abdominal fistula,
             gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound,
             ulcer, or bone fracture

          -  The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days
             before beginning and during treatment with sunitinib: azole antifungals (ketoconazole,
             itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and
             human immunodeficiency virus [HIV] protease inhibitors (indinavir, saquinavir,
             ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited
             within 12 days before beginning and during treatment with sunitinib: rifampin,
             rifabutin, carbamazepine, phenobarbital, phenytoin, St. John?s Wort, efavirenz,
             tipranavir; other inhibitors and inducers of CYP3A4 may be used if necessary, but
             their use is discouraged

          -  Patients unable to take oral medication are not eligible

          -  Granulocytes >= 1,500/mcl

          -  Platelet count >= 100,000/mcl

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=< 2.5 x ULN;
             patients with liver metastases may have AST and ALT =< 5 x ULN; all other patients
             will have AST and ALT =< 2.5 x ULN

          -  Creatinine =< 1.5 mg/dl