Last updated on December 2018

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Small Cell Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

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
  • 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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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