A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
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.
Checked against the public recordLast updated Jul 29, 2021 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.