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

AbbVie

Status and phase: Terminated; Phase 3

Conditions: Small Cell Lung Cancer

Treatments: Drug: Placebo for rovalpituzumab tesirine; Drug: Placebo for dexamethasone; Drug: Rovalpituzumab tesirine; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03033511

2016-003503-64 (EudraCT Number)

M16-298

Details and patient eligibility

About

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.

Enrollment: 748 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

748 participants in 2 patient groups

Rovalpituzumab tesirine/dexamethasone

Experimental group

Description:

Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle

Treatment:

Drug: Rovalpituzumab tesirine

Drug: Dexamethasone

Placebo

Experimental group

Description:

Placebo q6 wk; omitting every third cycle

Treatment:

Drug: Placebo for dexamethasone

Drug: Placebo for rovalpituzumab tesirine