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) (TAHOE)
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|ClinicalTrials.gov Identifier: NCT03061812|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Rovalpituzumab tesirine Drug: Topotecan||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for High DLL3 Expressing Small Cell Lung Cancer (SCLC) Subjects With First Relapse/Recurrence Following Front-Line Platinum-Based Chemotherapy (TAHOE)|
|Actual Study Start Date :||April 10, 2017|
|Estimated Primary Completion Date :||September 19, 2019|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Rovalpituzumab tesirine
Rovalpituzumab tesirine intravenous administration on Day 1 of a 42-Day cycle for 2 cycles.
Drug: Rovalpituzumab tesirine
Administered on Day 1 via intravenous infusion in a 42-day cycle for 2 cycles.
Active Comparator: Topotecan
Topotecan intravenous on Days 1 through 5 of each 21-Day cycle.
Administered on Day 1-5 via intravenous infusion in a 21-day cycle.
- Overall Survival (OS) [ Time Frame: Approximately 34 months ]Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
- Objective response rate (ORR) [ Time Frame: Approximately 34 months ]ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Change from baseline of the Physical functioning scale score in QLQ-C15-PAL [ Time Frame: Approximately 34 months ]European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC OLQ-C15-PAL) is a questionnaire developed to assess the quality of life of palliative cancer care. Higher scores reflect greater symptom burden.
- Progression Free Survival (PFS) [ Time Frame: Approximately 34 months ]PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.
- Duration of Objective Response (DOR) [ Time Frame: Approximately 34 months ]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.
- Clinical Benefit Rate (CBR) [ Time Frame: Approximately 34 months ]CBR is defined as percentage of participants whose best overall response is complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061812
|Contact: ABBVIE CALL CENTERemail@example.com|
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|Study Director:||AbbVie Inc.||AbbVie|