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)

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. Identifier: NCT03061812
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : June 18, 2018
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Rovalpituzumab tesirine Drug: Topotecan Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Drug: Topotecan
Administered on Day 1-5 via intravenous infusion in a 21-day cycle.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03061812

Contact: ABBVIE CALL CENTER 847.283.8955

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Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie Identifier: NCT03061812     History of Changes
Other Study ID Numbers: M16-289
2016-003726-17 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Small cell lung cancer (SCLC)
Delta-like protein 3 (DLL3)
rovalpituzumab tesirine

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents