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NCT03061812 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
NCT03061812: Completed Phase 3 study, sponsored by AbbVie.
NCT03061812 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 444 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03061812, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 participants
- Enrollment target
Study Summary
The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
Primary Outcome
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-lim
Interventions
- DRUG Dexamethasone
- DRUG Topotecan
- DRUG Rovalpituzumab tesirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2017-04-11 |
| Est. Completion | 2020-02-12 |
| Phase | Phase 3 |
What the finished NCT03061812 record still lists
NCT03061812 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT03061812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03061812 about?
NCT03061812 is a clinical study titled "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)". The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line...
What is the current status of trial NCT03061812?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. The study started on 2017-04-11. Estimated completion is 2020-02-12.
What interventions are being tested in trial NCT03061812?
The interventions under investigation include: Dexamethasone (DRUG), Topotecan (DRUG), Rovalpituzumab tesirine (DRUG).
Who is sponsoring clinical trial NCT03061812?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061812's enrollment target sits among peer trials
444 864th of 2000 higher than 1,135 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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