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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPlacebo for dexamethasone and Placebo for rovalpituzumab tesirine

Plus 2 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 29, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?308 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: AbbVie
Interventions being studied: Drug: Placebo for dexamethasone; Drug: Placebo for rovalpituzumab tesirine; Drug: Rovalpituzumab tesirine; Drug: Dexamethasone

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis 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
Participant is eligible to be randomized 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
Availability of archived or representative tumor material for assessment of DLL3 expression

Reasons someone may not be able to joinExclusion 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 for SCLC.
Any disease-directed radiotherapy (except prophylactic cranial irradiation, 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-based) 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Clearview Cancer Institute /ID# 156699Huntsville, Alabama
University of South Alabama /ID# 160975Mobile, Alabama
Highlands Oncology Group /ID# 156722Fayetteville, Arkansas
Marin Cancer Care /ID# 159207Greenbrae, California
Ucsd /Id# 157764La Jolla, California
LA Hem-Oncology Med Group /ID# 156717Los Angeles, California
Palo Alto Veterans Institute for Research /ID# 203695Palo Alto, California
St Jude Hospital dba St Joseph /ID# 156526Santa Rosa, California
Icri /Id# 157765Whittier, California
Kaiser Permanente Lone Tree /ID# 159331Lone Tree, Colorado
Christiana Care Health Service /ID# 159212Newark, Delaware
Holy Cross Hospital /ID# 156716Fort Lauderdale, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 29, 2021. Always confirm current availability with the study team.

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