Summary

for people ages 18 years and up (full criteria)
at UCSD
study started
estimated completion:

Description

Summary

This is a Phase 3, 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.

Official Title

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)

Keywords

Small Cell Lung Cancer Extensive-Stage Small Cell Lung Cancer (ED SCLC) Cancer Platinum-Based Chemotherapy Rovalpituzumab tesirine first-line chemotherapy (SCLC) Lung Neoplasms Small Cell Lung Carcinoma Dexamethasone acetate Dexamethasone BB 1101 Rovalpituzumab tesirine/dexamthasone

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Ucsd /Id# 157764 accepting new patients
    La Jolla California 92037 United States
  • LA Hem-Oncology Med Group /ID# 156717 accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03033511
Phase
Phase 3
Study Type
Interventional
Last Updated