A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Placebo for dexamethasone; Placebo for rovalpituzumab tesirine; Rovalpituzumab tesirine; Dexamethasone
Intervention description: Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.; Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle; Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle; Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101; Rovalpituzumab tesirine; Immunoconjugates
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 748.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extensive-Stage Small Cell Lung Cancer (ED SCLC); Cancer; Platinum-Based Chemotherapy; Rovalpituzumab tesirine; first-line chemotherapy; Small Cell Lung Cancer (SCLC); Delta-like protein 3 (DLL3)

Summary:

      This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and
      multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy
      following first-line platinum-based chemotherapy.
    

Eligibility criteria:

        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.