A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
To evaluate if rovalpituzumab tesirine improves progression-free and overall survival in subjects with extensive-stage small cell lung cancer (ED SCLC) who have ongoing clinical benefit (SD,PR, or CR) following first-line platinum-based chemotherapy (cisplatin or carboplatin plus irinotecan or etoposide) compared to placebo.Inclusion Criteria:
- Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) 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
- At least 3 but no more than 9 weeks between the administration of the last cycle of platinum-based chemotherapy and randomization.
- 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
- 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
- Any disease-directed radiotherapy (except prophylactic cranial irradiation 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)- 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.
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Keywordsrovalpituzumab tesirine , small cell lung cancer, chemotherapy, cancer
Principal InvestigatorDennie Jones, Jr, M.D.
Sponsoring GroupDepartment of Medicine
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