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)

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.

Study Start Date

April, 10 2017

Estimated Completion Date

May 2020

Interventions

  • Drug: Rovalpituzumab tesirine
  • Drug: Topotecan

Study ID

AbbVie -- M16-289

Status

Recruiting

Trial ID

NCT03061812

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

411

Sponsor

AbbVie

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.

Gender

All

Ages

18 Years to 99 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (120)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute ID 160210 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 160210 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 160210 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 160210 - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute ID 160210 - Boston, Massachusetts 2.4 miles None None None
Christiana Care Health Services Inc ID 158171 - Newark, Delaware 305.1 miles None None None
Christiana Care Health Services Inc ID 158171 - Newark, Delaware 305.1 miles None None None
Christiana Care Health Services Inc ID 158171 - Newark, Delaware 305.1 miles None None None
Christiana Care Health Services Inc ID 158171 - Newark, Delaware 305.1 miles None None None
Christiana Care Health Services Inc ID 158171 - Newark, Delaware 305.1 miles None None None
West Virginia University School of Medicine ID 155872 - Morgantown, West Virginia 501.0 miles None None None
West Virginia University School of Medicine ID 155872 - Morgantown, West Virginia 501.0 miles None None None
West Virginia University School of Medicine ID 155872 - Morgantown, West Virginia 501.0 miles None None None
West Virginia University School of Medicine ID 155872 - Morgantown, West Virginia 501.0 miles None None None
West Virginia University School of Medicine ID 155872 - Morgantown, West Virginia 501.0 miles None None None
Gabrail Cancer Center Research ID 155920 - Canton, Ohio 545.3 miles None None None
Gabrail Cancer Center Research ID 155920 - Canton, Ohio 545.3 miles None None None
Gabrail Cancer Center Research ID 155920 - Canton, Ohio 545.3 miles None None None
Gabrail Cancer Center Research ID 155920 - Canton, Ohio 545.3 miles None None None
Gabrail Cancer Center Research ID 155920 - Canton, Ohio 545.3 miles None None None
Edward W Sparrow Hospital Association ID 157021 - Lansing, Michigan 684.6 miles None None None
Edward W Sparrow Hospital Association ID 157021 - Lansing, Michigan 684.6 miles None None None
Edward W Sparrow Hospital Association ID 157021 - Lansing, Michigan 684.6 miles None None None
Edward W Sparrow Hospital Association ID 157021 - Lansing, Michigan 684.6 miles None None None
Edward W Sparrow Hospital Association ID 157021 - Lansing, Michigan 684.6 miles None None None
Goshen Center for Cancer Care ID 155946 - Goshen, Indiana 759.4 miles None None None
Goshen Center for Cancer Care ID 155946 - Goshen, Indiana 759.4 miles None None None
Goshen Center for Cancer Care ID 155946 - Goshen, Indiana 759.4 miles None None None
Goshen Center for Cancer Care ID 155946 - Goshen, Indiana 759.4 miles None None None
Goshen Center for Cancer Care ID 155946 - Goshen, Indiana 759.4 miles None None None
University Medical Center Inc ID 155947 - Louisville, Kentucky 823.2 miles None None None
University Medical Center Inc ID 155947 - Louisville, Kentucky 823.2 miles None None None
University Medical Center Inc ID 155947 - Louisville, Kentucky 823.2 miles None None None
University Medical Center Inc ID 155947 - Louisville, Kentucky 823.2 miles None None None
University Medical Center Inc ID 155947 - Louisville, Kentucky 823.2 miles None None None
NorthShore University HealthSystem ID 157054 - Evanston, Illinois 850.4 miles None None None
NorthShore University HealthSystem ID 157054 - Evanston, Illinois 850.4 miles None None None
NorthShore University HealthSystem ID 157054 - Evanston, Illinois 850.4 miles None None None
NorthShore University HealthSystem ID 157054 - Evanston, Illinois 850.4 miles None None None
NorthShore University HealthSystem ID 157054 - Evanston, Illinois 850.4 miles None None None
Ingalls Memorial Hospital ID 155871 - Harvey, Illinois 853.1 miles None None None
Ingalls Memorial Hospital ID 155871 - Harvey, Illinois 853.1 miles None None None
Ingalls Memorial Hospital ID 155871 - Harvey, Illinois 853.1 miles None None None
Ingalls Memorial Hospital ID 155871 - Harvey, Illinois 853.1 miles None None None
Ingalls Memorial Hospital ID 155871 - Harvey, Illinois 853.1 miles None None None
Georgia Cancer Center Specialists ID 160206 - Atlanta, Georgia 929.9 miles None None None
Georgia Cancer Center Specialists ID 160206 - Atlanta, Georgia 929.9 miles None None None
Georgia Cancer Center Specialists ID 160206 - Atlanta, Georgia 929.9 miles None None None
Georgia Cancer Center Specialists ID 160206 - Atlanta, Georgia 929.9 miles None None None
Georgia Cancer Center Specialists ID 160206 - Atlanta, Georgia 929.9 miles None None None
Nebraska Hematology Oncology PC ID 155900 - Nashville, Tennessee 942.8 miles None None None
Nebraska Hematology Oncology PC ID 155900 - Nashville, Tennessee 942.8 miles None None None
Nebraska Hematology Oncology PC ID 155900 - Nashville, Tennessee 942.8 miles None None None
Nebraska Hematology Oncology PC ID 155900 - Nashville, Tennessee 942.8 miles None None None
Nebraska Hematology Oncology PC ID 155900 - Nashville, Tennessee 942.8 miles None None None
Clearview Cancer Institute ID 155873 - Huntsville, Alabama 991.2 miles None None None
Clearview Cancer Institute ID 155873 - Huntsville, Alabama 991.2 miles None None None
Clearview Cancer Institute ID 155873 - Huntsville, Alabama 991.2 miles None None None
Clearview Cancer Institute ID 155873 - Huntsville, Alabama 991.2 miles None None None
Clearview Cancer Institute ID 155873 - Huntsville, Alabama 991.2 miles None None None
University of South Alabama Mitchell Cancer Institute ID 158151 - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute ID 158151 - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute ID 158151 - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute ID 158151 - Mobile, Alabama 1,239.6 miles None None None
University of South Alabama Mitchell Cancer Institute ID 158151 - Mobile, Alabama 1,239.6 miles None None None
Central Arkansas Radiation Therapy Institute ID 156982 - Little Rock, Arkansas 1,261.1 miles None None None
Central Arkansas Radiation Therapy Institute ID 156982 - Little Rock, Arkansas 1,261.1 miles None None None
Central Arkansas Radiation Therapy Institute ID 156982 - Little Rock, Arkansas 1,261.1 miles None None None
Central Arkansas Radiation Therapy Institute ID 156982 - Little Rock, Arkansas 1,261.1 miles None None None
Central Arkansas Radiation Therapy Institute ID 156982 - Little Rock, Arkansas 1,261.1 miles None None None
Highlands Oncology Group ID 155902 - Fayetteville, Arkansas 1,305.8 miles None None None
Highlands Oncology Group ID 155902 - Fayetteville, Arkansas 1,305.8 miles None None None
Highlands Oncology Group ID 155902 - Fayetteville, Arkansas 1,305.8 miles None None None
Highlands Oncology Group ID 155902 - Fayetteville, Arkansas 1,305.8 miles None None None
Highlands Oncology Group ID 155902 - Fayetteville, Arkansas 1,305.8 miles None None None
Ochsner Clinic Foundation ID 160807 - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation ID 160807 - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation ID 160807 - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation ID 160807 - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Clinic Foundation ID 160807 - New Orleans, Louisiana 1,363.3 miles None None None
University Medical Center Brackenridge ID 156967 - Austin, Texas 1,696.1 miles None None None
University Medical Center Brackenridge ID 156967 - Austin, Texas 1,696.1 miles None None None
University Medical Center Brackenridge ID 156967 - Austin, Texas 1,696.1 miles None None None
University Medical Center Brackenridge ID 156967 - Austin, Texas 1,696.1 miles None None None
University Medical Center Brackenridge ID 156967 - Austin, Texas 1,696.1 miles None None None
Medical Oncology Associates PS dba Summit Cancer Centers ID 156856 - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS dba Summit Cancer Centers ID 156856 - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS dba Summit Cancer Centers ID 156856 - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS dba Summit Cancer Centers ID 156856 - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS dba Summit Cancer Centers ID 156856 - Spokane, Washington 2,263.5 miles None None None
Seattle Cancer Care Alliance ID 162626 - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance ID 162626 - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance ID 162626 - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance ID 162626 - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance ID 162626 - Seattle, Washington 2,490.2 miles None None None
Oregon Health Science University OHSU ID 157055 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 157055 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 157055 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 157055 - Portland, Oregon 2,538.3 miles None None None
Oregon Health Science University OHSU ID 157055 - Portland, Oregon 2,538.3 miles None None None
Innovative Clinical Research Institute ID 157090 - Whittier, California 2,585.9 miles None None None
Innovative Clinical Research Institute ID 157090 - Whittier, California 2,585.9 miles None None None
Innovative Clinical Research Institute ID 157090 - Whittier, California 2,585.9 miles None None None
Innovative Clinical Research Institute ID 157090 - Whittier, California 2,585.9 miles None None None
Innovative Clinical Research Institute ID 157090 - Whittier, California 2,585.9 miles None None None
Los Angeles Hematology Oncology Medical Group ID 155879 - Los Angeles, California 2,596.3 miles None None None
Los Angeles Hematology Oncology Medical Group ID 155879 - Los Angeles, California 2,596.3 miles None None None
Los Angeles Hematology Oncology Medical Group ID 155879 - Los Angeles, California 2,596.3 miles None None None
Los Angeles Hematology Oncology Medical Group ID 155879 - Los Angeles, California 2,596.3 miles None None None
Los Angeles Hematology Oncology Medical Group ID 155879 - Los Angeles, California 2,596.3 miles None None None
University of California Davis Comprehensive Cancer Center ID 157001 - Sacramento, California 2,628.4 miles None None None
University of California Davis Comprehensive Cancer Center ID 157001 - Sacramento, California 2,628.4 miles None None None
University of California Davis Comprehensive Cancer Center ID 157001 - Sacramento, California 2,628.4 miles None None None
University of California Davis Comprehensive Cancer Center ID 157001 - Sacramento, California 2,628.4 miles None None None
University of California Davis Comprehensive Cancer Center ID 157001 - Sacramento, California 2,628.4 miles None None None
St Jude Hospital dba St Joseph Heritage Healthcare ID 155899 - Santa Rosa, California 2,695.0 miles None None None
St Jude Hospital dba St Joseph Heritage Healthcare ID 155899 - Santa Rosa, California 2,695.0 miles None None None
St Jude Hospital dba St Joseph Heritage Healthcare ID 155899 - Santa Rosa, California 2,695.0 miles None None None
St Jude Hospital dba St Joseph Heritage Healthcare ID 155899 - Santa Rosa, California 2,695.0 miles None None None
St Jude Hospital dba St Joseph Heritage Healthcare ID 155899 - Santa Rosa, California 2,695.0 miles None None None

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