A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
TerminatedPhase 3Results postedLast updated 29 July 2021
What this trial tests
Phase 3 trial testing Placebo for dexamethasone in Small Cell Lung Cancer in 748 participants. Terminated before completion.
18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)Primary· 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.
Group
Value
95% CI
Placebo
9.79
8.38 – 10.87
Rovalpituzumab Tesirine/Dexamethasone
8.48
7.26 – 10.18
OS in All Randomized ParticipantsSecondary· 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.
Group
Value
95% CI
Placebo
9.89
8.61 – 11.01
Rovalpituzumab Tesirine/Dexamethasone
8.80
7.95 – 9.53
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over TimeSecondary· 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 tran
Change at Week 6
Group
Value
95% CI
Placebo
-3.97
± 1.00
Rovalpituzumab Tesirine/Dexamethasone
-4.34
± 0.95
Change at Week 12
Group
Value
95% CI
Placebo
-1.70
± 1.67
Rovalpituzumab Tesirine/Dexamethasone
-12.13
± 1.27
Change at Week 18
Group
Value
95% CI
Placebo
8.15
± 4.02
Rovalpituzumab Tesirine/Dexamethasone
-19.52
± 4.92
Change at Week 24
Group
Value
95% CI
Placebo
-0.95
± 7.32
Rovalpituzumab Tesirine/Dexamethasone
-19.39
± 6.61
Change at Week 30
Group
Value
95% CI
Placebo
5.33
± 4.22
Rovalpituzumab Tesirine/Dexamethasone
-16.67
± 6.78
Change at Week 36
Group
Value
95% CI
Placebo
-13.33
± NA
Rovalpituzumab Tesirine/Dexamethasone
-13.33
± NA
Change at Week 42
Group
Value
95% CI
Placebo
-6.67
± NA
Rovalpituzumab Tesirine/Dexamethasone
-3.33
± NA
Change at Week 48
Group
Value
95% CI
Placebo
-6.67
± NA
Rovalpituzumab Tesirine/Dexamethasone
-63.33
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 87/373 (23%)
Deaths: 201/376
Rovalpituzumab Tesirine/Dexamethasone
Serious: 157/368 (43%)
Deaths: 226/372
Serious adverse events (188 terms)
Reaction
System
Placebo
Rovalpituzumab Tesirine/De…
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
—
—
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
PNEUMONIA
Infections and infestations
—
—
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
—
—
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
—
—
THROMBOCYTOPENIA
Blood and lymphatic system disorders
—
—
METASTASES TO CENTRAL NERVOUS SYSTEM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03334487 — Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or R
· Phase 3
· withdrawn
NCT03086239 — A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Ce
· Phase 1
· completed
NCT03061812 — Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer
· Phase 3
· completed
NCT03026166 — A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults
· Phase 1, PHASE2
· terminated
NCT02709889 — Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
· Phase 1, PHASE2
· terminated
Other recruiting trials for Small Cell Lung Cancer
Currently open trials in the same condition.
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NCT06922539 — ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
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NCT07373964 — A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 29 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03033511.