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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)

NCT03061812

Description:

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.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief 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)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: M16-289
  • SECONDARY ID: 2016-003726-17
  • NCT ID: NCT03061812

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Rovalpituzumab tesirineRovalpituzumab tesirine
TopotecanTopotecan

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Rovalpituzumab tesirineExperimentalRovalpituzumab tesirine intravenous administration on Day 1 of a 42-Day cycle for 2 cycles.
  • Rovalpituzumab tesirine
TopotecanActive ComparatorTopotecan intravenous on Days 1 through 5 of each 21-Day cycle.
  • Topotecan

Eligibility Criteria

        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 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Approximately 34 months
Safety Issue:
Description:Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.

Secondary Outcome Measures

Measure:Change from baseline of the Physical functioning scale score in QLQ-C15-PAL
Time Frame:Approximately 34 months
Safety Issue:
Description: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.
Measure:Progression Free Survival (PFS)
Time Frame:Approximately 34 months
Safety Issue:
Description: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.
Measure:Duration of Objective Response (DOR)
Time Frame:Approximately 34 months
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Small cell lung cancer (SCLC)
  • Delta-like protein 3 (DLL3)
  • rovalpituzumab tesirine
  • topotecan
  • metastatic

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