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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

Learn more about lung cancer

     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Patricia Rich