A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | February 7, 2017 |
End Date: | September 22, 2022 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
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)
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.
multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy
following first-line platinum-based chemotherapy.
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.
We found this trial at
55
sites
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