Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

Inclusion Criteria:

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

- Minimum life expectancy of at least 12 weeks.

- Laboratory values meeting the criteria specified in the protocol.

- Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with
documented disease progression after at least 2 prior systemic regimens, including at
least one platinum-based regimen.

- Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry
(IHC) assessment of banked or otherwise representative tumor tissue.

- Measurable disease as described per protocol.

- In participants with a history of central nervous system (CNS) metastases,
documentation of stable or improved status based on brain imaging for at least 2 weeks
after completion of definitive treatment and within 2 weeks prior to first dose of
study drug, off or on a stable dose of corticosteroids.

Exclusion Criteria:

- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association Class III - IV within 6 months prior to first dose of study drug.

- Recent or on-going serious infection.

- History of other invasive malignancy that has not been in remission for at least 3
years.

- History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known
hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug
formulation.

- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.

- Documented history of capillary leak syndrome.

- Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational
drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing
requirements for pericardiocentesis or thoracentesis.