A Phase 3 interventional study of Placebo for dexamethasone and Placebo for rovalpituzumab tesirine in Small Cell Lung Cancer, sponsored by AbbVie. Terminated at 308 sites in 41 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-29.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 748 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Drug: Rovalpituzumab tesirine · Drug: Dexamethasone
Placebo q6 wk; omitting every third cycle
Drug: Placebo for dexamethasone · Drug: Placebo for rovalpituzumab tesirine
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 rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
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.
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Time frame: 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 in All Randomized Participants
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Time frame: 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.
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
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.
Time frame: Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)
| Milestone | Placebo | Rovalpituzumab Tesirine/Dexamethasone |
|---|---|---|
| Started | 376 | 372 |
| Completed | 376 | 372 |
| Not completed | 0 | 0 |
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
| months | Placebo | Rovalpituzumab Tesirine/Dexamethasone |
|---|---|---|
| Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high) | 9.79 (8.38 to 10.87) | 8.48 (7.26 to 10.18) |
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
| months | Placebo | Rovalpituzumab Tesirine/Dexamethasone |
|---|---|---|
| OS in All Randomized Participants | 9.89 (8.61 to 11.01) | 8.80 (7.95 to 9.53) |
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.
| score on a scale | Placebo | Rovalpituzumab Tesirine/Dexamethasone |
|---|---|---|
| Change at Week 6 | -3.97 ± 1.00 | -4.34 ± 0.95 |
| Change at Week 12 | -1.70 ± 1.67 | -12.13 ± 1.27 |
| Change at Week 18 | 8.15 ± 4.02 | -19.52 ± 4.92 |
| Change at Week 24 | -0.95 ± 7.32 | -19.39 ± 6.61 |
| Change at Week 30 | 5.33 ± 4.22 | -16.67 ± 6.78 |
| Change at Week 36 | -13.33 ± NA | -13.33 ± NA |
| Change at Week 42 | -6.67 ± NA | -3.33 ± NA |
| Change at Week 48 | -6.67 ± NA | -63.33 ± NA |
| Change at Week 54 | -6.67 ± NA | — |
| Change at Week 60 | 0.00 ± NA | 0.00 ± NA |
| Change at Week 66 | 0.00 ± NA | 0.00 ± NA |
| Change at Week 72 | 0.00 ± NA | — |
| Change at Week 78 | 0.00 ± NA | 0.00 ± NA |
| Change at Week Final Visit | -4.14 ± 1.02 | -13.31 ± 1.12 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 201/376 (53.5%) | 87/373 (23.3%) | 248/373 (66.5%) |
| Rovalpituzumab Tesirine/Dexamethasone | 226/372 (60.8%) | 157/368 (42.7%) | 315/368 (85.6%) |
| Event | Placebo | Rovalpituzumab Tesirine/Dexamethasone |
|---|---|---|
| PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders | 2/373 | 22/368 |
| MALIGNANT NEOPLASM PROGRESSIONNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 21/373 | 16/368 |
| PNEUMONIAInfections and infestations | 8/373 | 14/368 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 4/373 | 12/368 |
| GENERAL PHYSICAL HEALTH DETERIORATIONGeneral disorders | 8/373 | 9/368 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 0/373 | 8/368 |
| METASTASES TO CENTRAL NERVOUS SYSTEMNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 7/373 | 7/368 |
| PNEUMONITISRespiratory, thoracic and mediastinal disorders | 0/373 | 7/368 |
| ABDOMINAL PAINGastrointestinal disorders | 2/373 | 6/368 |
| SEPSISInfections and infestations | 2/373 | 6/368 |
| Event | Placebo | Rovalpituzumab Tesirine/Dexamethasone |
|---|---|---|
| DECREASED APPETITEMetabolism and nutrition disorders | 49/373 | 95/368 |
| OEDEMA PERIPHERALGeneral disorders | 28/373 | 93/368 |
| FATIGUEGeneral disorders | 60/373 | 91/368 |
| PHOTOSENSITIVITY REACTIONSkin and subcutaneous tissue disorders | 5/373 | 88/368 |
| NAUSEAGastrointestinal disorders | 51/373 | 77/368 |
| PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders | 11/373 | 76/368 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 39/373 | 67/368 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 14/373 | 61/368 |
| PERICARDIAL EFFUSIONCardiac disorders | 6/373 | 58/368 |
| COUGHRespiratory, thoracic and mediastinal disorders | 43/373 | 56/368 |
| Age, Continuous(years) | Placebo | Rovalpituzumab Tesirine/Dexamethasone | Total |
|---|---|---|---|
| Mean | 63.8 ± 8.20 | 64.1 ± 8.40 | 63.9 ± 8.29 |
| Sex: Female, Male(Participants) | Placebo | Rovalpituzumab Tesirine/Dexamethasone | Total |
|---|---|---|---|
| Female | 137 | 114 | 251 |
| Male | 239 | 258 | 497 |
| Race/Ethnicity, Customized(Participants) | Placebo | Rovalpituzumab Tesirine/Dexamethasone | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 15 | 33 |
| Not Hispanic or Latino | 356 | 355 | 711 |
| Missing | 2 | 2 | 4 |
| Race/Ethnicity, Customized(Participants) | Placebo | Rovalpituzumab Tesirine/Dexamethasone | Total |
|---|---|---|---|
| White | 301 | 314 | 615 |
| Black or African American | 7 | 2 | 9 |
| Asian | 66 | 55 | 121 |
| American Indian or Alaska Native | 2 | 0 | 2 |
| Multiple Races | 0 | 1 | 1 |
Showing the first 100 of 308 sites across 41 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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