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Trial record 1 of 1 for:    NCT03061812
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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)

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT03061812
First Posted: February 23, 2017
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
February 20, 2017
February 23, 2017
November 2, 2017
April 10, 2017
September 19, 2019   (Final data collection date for primary outcome measure)
  • Objective response rate (ORR) [ Time Frame: Approximately 23 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.
  • 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.
Same as current
Complete list of historical versions of study NCT03061812 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
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 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)
The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: Rovalpituzumab tesirine
    Administered on Day 1 via intravenous infusion in a 42-day cycle for 2 cycles.
  • Drug: Topotecan
    Administered on Day 1-5 via intravenous infusion in a 21-day cycle.
  • Experimental: Rovalpituzumab tesirine
    Rovalpituzumab tesirine intravenous administration on Day 1 of a 42-Day cycle for 2 cycles.
    Intervention: Drug: Rovalpituzumab tesirine
  • Active Comparator: Topotecan
    Topotecan intravenous on Days 1 through 5 of each 21-Day cycle.
    Intervention: Drug: Topotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
411
May 2, 2020
September 19, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen
  • Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
  • Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per the Central Radiographic Assessment Committee (CRAC).
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.

Exclusion Criteria:

  • Participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class (NYHA) III - IV within 6 months prior to their first dose of study drug.
  • Participant has known leptomeningeal metastases.
  • Participant has received more than one prior systemic therapy regimen for SCLC.
  • Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
  • Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
  • Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact: AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com
Australia,   Belarus,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Latvia,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
 
 
NCT03061812
M16-289
2016-003726-17 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Philip Komarnitsky, MD AbbVie
AbbVie
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP