1. Age ≥ 18 years male or female (in certain territories, the minimum age requirement
may be higher e.g., age > 20 years in Japan and Taiwan, age > 21 years in Singapore)
2. Prior platinum treatment is required
4. Capable of providing informed consent and complying with trial procedures
5. If feasible and clinically indicated, must have received vaccinations for influenza, pneumococci, H. influenzae type B and Hepatitis B at least 2 weeks before starting
7. Life expectancy of ≥ 12 weeks
10. Prior chemoembolization, radiofrequency ablation, or radiation is allowed as long as the patient has measurable disease and the lesion(s) that is being measured is 1) at least
12 weeks out from palliative therapy and 2) exhibits increased measurable growth
13. Accessibility to the site that ensures the patient will be able to keep all study-related appointments
14. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for 90 days
following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Note: A woman of child-bearing potential is any female (regardless of sexual
orientation, having undergone a tubal ligation, or remaining celibate by choice) who
meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months
(i.e., has had menses at any time in the preceding 12 consecutive months)