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MERU: A randomized, double-blind, placebo-controlled phase III study of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based Chemotherapy in subjects with extensive stage small cell lung cancer

Description

This is a phase III, 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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objectives of this study are:

  • Progression-free survival determined by a Central Radiographic Assessment Committee
  • Overall survival

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who have:

  • Histologically or cytologically confirmed extensive-stage disease small cell lung cancer  with ongoing clinical benefit (stable disease, partial response, or complete response) following completion of four cycles of first-line platinum-based therapy
  • Had at least three but no more than nine weeks between the administration of the last cycle of platinum-based chemotherapy and randomization
  • Received (as a must) definitive local treatment and have documentation of stable or improved CNS disease status if they have a history of central nervous system metastases prior to the initiation of first-line platinum-based chemotherapy 
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Adequate bone marrow, renal and hepatic function
  • Available archived or representative tumor material for assessment of DLL3 expression

Excluding patients who have had:

  • 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