E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.

Inclusion criteria:

1. Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
2. Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
3. Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
4. Subjects with Performance Status (PS) 0-1.
5. Subjects with adequate organ function.

Exclusion criteria:

1. Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):

   1. Chemotherapy
   2. Biological or immunotherapies
   3. Surgery for primary focus
   4. The radiation therapy for primary focus

2. Subjects with the severe complications or disease history.

3. Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.

4. Subjects with simultaneous or metachronous cancers.

5. Subjects who cannot take oral medication.

6. Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.