
    independent data monitoring committee recommendation
  
['small cell lung cancer']
['placebo for dexamethasone', 'placebo for rovalpituzumab tesirine', 'rovalpituzumab tesirine', 'dexamethasone']

        Inclusion Criteria:

          -  Histologically or cytologically confirmed extensive-stage disease small cell lung
             cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease
             [SD], partial response [PR], or complete response [CR]) following completion of 4
             cycles of first-line platinum-based therapy

          -  Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day
             1 of the fourth cycle of first-line platinum-based chemotherapy.

          -  Participants with a history of central nervous system (CNS) metastases prior to the
             initiation of first-line platinum-based chemotherapy must have received definitive
             local treatment and have documentation of stable or improved CNS disease status

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

          -  Participants must have adequate bone marrow, renal and hepatic function

          -  Availability of archived or representative tumor material for assessment of DLL3
             expression

        Exclusion Criteria:

          -  Any 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
             anti-cancer therapy than that described in inclusion criteria for SCLC.

          -  Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative
             radiotherapy to a radiographically documented non-progressing lesion for symptom
             control, or pre-planned radiotherapy for CNS metastases present prior to start of
             first-line therapy and non-progressing) after last dose of first-line chemotherapy.

          -  Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based
             drug, prior participation in a rovalpituzumab tesirine clinical trial, or known
             hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient
             contained in the drug formulation.
      