A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Delta-Like Protein 3-Expressing Extensive Stage Small Cell Lung Cancer

Inclusion Criteria:

- Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage,
chemotherapy-naïve SCLC

- DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive
is defined as staining in ≥75% of tumor cells.

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

- Minimum life expectancy of at least 12 weeks.

- Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior
to initiation of study drug.

- Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb,
total bilirubin, ALT, AST and GFR)

- Subjects with a history of CNS metastases must have completed definitive treatment
prior to first dose of study treatment, off or on a stable dose of corticosteroids

- Use of effective contraception method during and for 1 year following study drug
dosing if female of childbearing potential or sexually active male

Exclusion Criteria:

- Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors,
other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell
or other cell-based or biologic therapies, or any other anticancer therapy for the
treatment of (limited or extensive) SCLC.

- Any significant medical condition, that, in the opinion of the investigator or
sponsor, may place the subject at undue risk from the study.

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

- Recent or ongoing serious infection.

- Women who are pregnant or breastfeeding.

- History of another invasive malignancy that has not been in remission for at least 3
years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate
cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on
PAP smear.

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