Trial · NCT03033511
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, Phase 3, Terminated, AbbVie; results first posted 2020-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU). Trials, record NCT03033511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03033511
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
- NCT number
- NCT03033511
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 748 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Small Cell Lung Cancer
- Interventions
- Placebo for dexamethasone, Placebo for rovalpituzumab tesirine, Rovalpituzumab tesirine, Dexamethasone
- First posted
- 2017-01-26
- Last updated
- 2021-07-29
- Other registries' IDs
- eudract:2016-003503-64
- Results first posted
- 2020-12-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 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. | months | MEDIAN |
| SECONDARY | 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. | Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received. | months | MEDIAN |
| SECONDARY | 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) | 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. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high) | Placebo | 9.79 | 95% Confidence Interval 8.38 to 10.87 | months | |
| Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high) | Rovalpituzumab Tesirine/Dexamethasone | 8.48 | 95% Confidence Interval 7.26 to 10.18 | months | |
| OS in All Randomized Participants | Placebo | 9.89 | 95% Confidence Interval 8.61 to 11.01 | months | |
| OS in All Randomized Participants | Rovalpituzumab Tesirine/Dexamethasone | 8.80 | 95% Confidence Interval 7.95 to 9.53 | months | |
| 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 | Placebo | Change at Week 6 | -3.97 | Standard Error 1.00 | score on a scale |
| 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 | Rovalpituzumab Tesirine/Dexamethasone | Change at Week 6 | -4.34 | Standard Error 0.95 | score on a scale |
| 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 | Placebo | Change at Week 12 | -1.70 | Standard Error 1.67 | score on a scale |
| 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 | Rovalpituzumab Tesirine/Dexamethasone | Change at Week 12 | -12.13 | Standard Error 1.27 | score on a scale |
| 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 | Placebo | Change at Week 18 | 8.15 | Standard Error 4.02 | score on a scale |
| 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 | Rovalpituzumab Tesirine/Dexamethasone | Change at Week 18 | -19.52 | Standard Error 4.92 | score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 376 | |
| Overall Study | STARTED | Rovalpituzumab Tesirine/Dexamethasone | 372 | |
| Overall Study | COMPLETED | Placebo | 376 | |
| Overall Study | COMPLETED | Rovalpituzumab Tesirine/Dexamethasone | 372 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rovalpituzumab Tesirine/Dexamethasone | 0 |
Source ClinicalTrials.gov
Adverse events454
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo | 11 | 373 | 18 |
| other | ANAEMIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine/Dexamethasone | 45 | 368 | 51 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo | 10 | 373 | 11 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine/Dexamethasone | 31 | 368 | 37 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Placebo | 14 | 373 | 19 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine/Dexamethasone | 61 | 368 | 79 |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Placebo | 6 | 373 | 7 |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Rovalpituzumab Tesirine/Dexamethasone | 58 | 368 | 63 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 14 | 373 | 14 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Rovalpituzumab Tesirine/Dexamethasone | 21 | 368 | 24 |
1 to 10 of 454Source ClinicalTrials.gov
See all 454 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 201 | 376 |
| Total, all-cause mortality | Rovalpituzumab Tesirine/Dexamethasone | 226 | 372 |
| Total, other adverse events | Placebo | 248 | 373 |
| Total, other adverse events | Rovalpituzumab Tesirine/Dexamethasone | 315 | 368 |
| Total, serious adverse events | Placebo | 87 | 373 |
| Total, serious adverse events | Rovalpituzumab Tesirine/Dexamethasone | 157 | 368 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29290251 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rovalpituzumab Tesirine/Dexamethasone vs Placebo: deaths from any cause | Trial comparisons |
| Rovalpituzumab Tesirine/Dexamethasone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03033511
GET https://conductscience.org/api/trials/v1/NCT03033511/results?page=2