Trial · NCT03061812
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
NCT03061812, Phase 3, Completed, AbbVie; results first posted 2021-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE). Trials, record NCT03061812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03061812
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
- NCT number
- NCT03061812
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 444 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Small Cell Lung Cancer
- Interventions
- Rovalpituzumab tesirine, Topotecan, Dexamethasone
- First posted
- 2017-02-23
- Last updated
- 2021-02-23
- Other registries' IDs
- eudract:2016-003726-17
- Results first posted
- 2021-02-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method. |
| Secondary | Progression Free Survival (PFS) | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions. |
| Secondary | Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7 | Baseline, Week 7 | The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent). |
| Secondary | Objective Response Rate (ORR) | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Clinical Benefit Rate (CBR) | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Duration of Objective Response (DOR) | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | Randomized participants | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | Randomized participants | months | MEDIAN |
| SECONDARY | Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7 | Baseline, Week 7 | Randomized participants with an assessment at baseline and Week 7. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Objective Response Rate (ORR) | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | Randomized participants with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | Randomized participants with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. | Randomized participants with measurable disease at baseline, and a response. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Topotecan | 8.57 | 95% Confidence Interval 7.69 to 10.12 | months | |
| Overall Survival (OS) | Rovalpituzumab Tesirine | 6.34 | 95% Confidence Interval 5.55 to 7.33 | months | |
| Progression Free Survival (PFS) | Topotecan | 4.27 | 95% Confidence Interval 3.75 to 5.42 | months | |
| Progression Free Survival (PFS) | Rovalpituzumab Tesirine | 3.02 | 95% Confidence Interval 2.86 to 3.61 | months | |
Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7 | Topotecan | -7.16 | 95% Confidence Interval -11.95 to -2.36 | score on a scale | |
Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7 | Rovalpituzumab Tesirine | -7.66 | 95% Confidence Interval -11.31 to -4.01 | score on a scale | |
| Objective Response Rate (ORR) | Topotecan | 20.9 | 95% Confidence Interval 14.27 to 28.97 | percentage of participants | |
| Objective Response Rate (ORR) | Rovalpituzumab Tesirine | 14.6 | 95% Confidence Interval 10.75 to 19.26 | percentage of participants | |
| Clinical Benefit Rate (CBR) | Topotecan | 43.4 | 95% Confidence Interval 34.71 to 52.42 | percentage of participants | |
| Clinical Benefit Rate (CBR) | Rovalpituzumab Tesirine | 35.9 | 95% Confidence Interval 30.34 to 41.74 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topotecan | 148 | |
| Overall Study | STARTED | Rovalpituzumab Tesirine | 296 | |
| Overall Study | COMPLETED | Topotecan | 148 | |
| Overall Study | COMPLETED | Rovalpituzumab Tesirine | 296 | |
| Overall Study | NOT COMPLETED | Topotecan | 0 | |
| Overall Study | NOT COMPLETED | Rovalpituzumab Tesirine | 0 |
Source ClinicalTrials.gov
Adverse events424
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 | Topotecan | 75 | 129 | 136 |
| other | ANAEMIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine | 42 | 287 | 53 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Topotecan | 25 | 129 | 80 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine | 4 | 287 | 8 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Topotecan | 50 | 129 | 136 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine | 14 | 287 | 20 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Topotecan | 45 | 129 | 94 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Rovalpituzumab Tesirine | 39 | 287 | 75 |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Topotecan | 3 | 129 | 3 |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Rovalpituzumab Tesirine | 56 | 287 | 58 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topotecan | 115 | 148 |
| Total, all-cause mortality | Rovalpituzumab Tesirine | 262 | 296 |
| Total, other adverse events | Topotecan | 118 | 129 |
| Total, other adverse events | Rovalpituzumab Tesirine | 245 | 287 |
| Total, serious adverse events | Topotecan | 74 | 129 |
| Total, serious adverse events | Rovalpituzumab Tesirine | 160 | 287 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Topotecan vs Rovalpituzumab Tesirine: deaths from any cause | Trial comparisons |
| Topotecan vs Rovalpituzumab Tesirine: 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/NCT03061812
GET https://conductscience.org/api/trials/v1/NCT03061812/events?page=2