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

Phase 3

Terminated

Interventions: Drug: Placebo for dexamethasone
Drug: Rovalpituzumab tesirine
Drug: Placebo for rovalpituzumab tesirine
Drug: Dexamethasone

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo for dexamethasone	Placebo q6 wk; omitting every third cycle
Placebo	Placebo for rovalpituzumab tesirine	Placebo q6 wk; omitting every third cycle
Rovalpituzumab tesirine/dexamethasone	Dexamethasone	Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Rovalpituzumab tesirine/dexamethasone	Rovalpituzumab tesirine	Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)	Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.	OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

Secondary Outcome Measures

Name	Time	Method
OS in All Randomized Participants	Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.	OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time	Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)	The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.

Locations (308): Clearview Cancer Institute /ID# 156699
🇺🇸
Huntsville, Alabama, United States
University of South Alabama /ID# 160975
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Mobile, Alabama, United States
Highlands Oncology Group /ID# 156722
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Fayetteville, Arkansas, United States
Marin Cancer Care /ID# 159207
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Greenbrae, California, United States
Ucsd /Id# 157764
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La Jolla, California, United States
LA Hem-Oncology Med Group /ID# 156717
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Los Angeles, California, United States
Palo Alto Veterans Institute for Research /ID# 203695
🇺🇸
Palo Alto, California, United States
St Jude Hospital dba St Joseph /ID# 156526
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Santa Rosa, California, United States
Icri /Id# 157765
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Whittier, California, United States
Kaiser Permanente Lone Tree /ID# 159331
🇺🇸
Lone Tree, Colorado, United States
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Clearview Cancer Institute /ID# 156699
🇺🇸Huntsville, Alabama, United States