Clinical trial NCT01187615 (phase 1, status: terminated)
Conditions: small cell lung carcinoma
ICD codes: D02.20, D02.21, D02.22
Drugs: regorafenib (bay73-4506) - sequential / cisplatin / pemetrexed, regorafenib (bay73-4506) - continuous / cisplatin / pemetrexed
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years.

          -  Histological or cytological diagnosis of metastatic Stage IV or locally advanced,
             unresectable confirmed Stage IIIB nonsquamous Non-Small Cell Lung Cancer (NSCLC) not
             amenable to local therapy with curative intent.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2

          -  Life expectancy of at least 12 weeks.

          -  Adequate bone marrow, liver, and renal function

          -  Controlled blood pressure [defined as systolic Blood Pressure (BP) <=150 mmHg and
             diastolic Blood Pressure (BP) <= 90 mmHg]

          -  Men and women of childbearing potential enrolled in this study must use adequate
             barrier birth control measures during the course of the study

        Exclusion Criteria:

          -  Sensory neuropathy with sensory alterations or paresthesia (including tingling),
             interfering with function

          -  Hearing impairment

          -  Persistent proteinuria of Common Toxicity Criteria (CTC) Grade 3 or higher

          -  Cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class
             II; patients must not have unstable angina (anginal symptoms at rest) or new-onset
             angina (began within the last 3 months) or myocardial infarction within the past 6
             months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

          -  Brain metastasis: patients with neurological symptoms should undergo a Computerized
             Tomography (CT) scan / Magnetic Resonance Imaging (MRI) of the brain to exclude any
             new or progressive brain metastasis. Patients with brain metastases are excluded from
             the trial

          -  Arterial or venous thrombotic or embolic events such as cerebrovascular accident
             (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism
             within the 6 months before start of study medication

          -  Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
             (CTCAE) Grade 2 within 4 weeks prior to the start of study treatment. Clinically
             significant hemoptysis (1 teaspoon or more) in the past 3 months

          -  Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks prior to the start
             of study treatment

          -  Evidence or history of bleeding diathesis or coagulopathy

          -  Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of
             major blood vessels

          -  The effect of third space fluid, such as pleural effusion and ascites, on pemetrexed
             is unknown. In patients with clinically significant third space fluid, consideration
             should be given to draining the effusion prior to study start

          -  Patients with phaeochromocytoma Excluded Therapies and Medications, Previous and
             Concomitant

          -  Prior treatment with a systemic chemotherapy for metastatic NSCLC. Patients who
             underwent prior systemic treatment or radiotherapy for NSCLC in a neoadjuvant or
             adjuvant setting are eligible, but no chemotherapy treatment within the last 6 month
             prior to study entry is allowed