Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Dexamethasone acetate

Rovalpituzumab tesirine

BB 1101

Immunoconjugates

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

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

Placebo q6 wk; omitting every third cycle

Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.

Placebo for dexamethasone

Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Placebo for rovalpituzumab tesirine

Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.

AbbVie Inc.

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.

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

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)

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

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.

AbbVie

All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.

Placebo q6 wk; omitting every third cycle

Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle

Placebo

Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle

Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle

Rovalpituzumab Tesirine/Dexamethasone

Placebo every 6 weeks (q6 wk); omitting every third cycle

Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Global Medical Services

DLL3 High Set: all randomized participants with extensive-stage small cell lung cancer with delta-like protein 3 high expression in tumor (DLL3high), defined as ≥ 75% tumor cells staining positive according to the VENTANA DLL3 \[SP347\] immunohistochemistry \[IHC\] assay.

Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)

Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received.

OS in All Randomized Participants

Change at Week 6

Change at Week 12

Change at Week 18

Change at Week 24

Change at Week 30

Change at Week 36

Change at Week 42

Change at Week 48

Change at Week 54

Change at Week 60

Change at Week 66

Change at Week 72

Change at Week 78

Change at Week Final Visit

Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received. Participants with an assessment at given time point.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)	NCT03033511	Small Cell Lung...	Placebo for dex... Placebo for rov... Rovalpituzumab ... Dexamethasone	18 Years -	AbbVie
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)	NCT03033511	Small Cell Lung...	Placebo for dex... Placebo for rov... Rovalpituzumab ... Dexamethasone	18 Years -	AbbVie

Spots Global Cancer Trial Database for placebo for rovalpituzumab tesirine