A Randomized, Double-Blind, Placebo-Controlled Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)

Abbvie Deutschland GmbH & Co. KG0 sites748 target enrollmentApril 25, 2017

Overview

No summary available.

Registry

who.int

Start Date

April 25, 2017

End Date

November 29, 2019

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Histologically or cytologically confirmed ED SCLC (extensive stage disease at initial diagnosis) with ongoing clinical benefit (SD, PR, or CR per RECIST v.1\.1\) following completion of 4 cycles of first\-line platinum\-based therapy (cisplatin or carboplatin in combination with etoposide or
•irinotecan).
•Subject is eligible to be randomised 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 240

•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 3\-5 for SCLC
•Any disease\-directed radiotherapy (except, PCI, 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)\- 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.