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Trial record 1 of 1 for:    NCT03033511
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A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) (MERU)

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ClinicalTrials.gov Identifier: NCT03033511
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE February 7, 2017
Estimated Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC) in participants with ED SCLC tumors with a high level of DLL3 expression [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, as assessed by the CRAC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death of any cause, whichever occurs first.
  • Overall survival (OS) in participants with ED SCLC tumors with a high level of DLL3 expression [ Time Frame: Approximately 31 months since first subject enrolled ]
    OS is defined as the number of months from randomization to death of any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, as assessed by the CRAC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death of any cause, whichever occurs first.
  • Overall survival (OS) [ Time Frame: Approximately 31 months since first subject enrolled ]
    OS is defined as the number of months from randomization to death of any cause.
Change History Complete list of historical versions of study NCT03033511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Change in patient reported outcomes (PROs)--physical functioning domain [ Time Frame: Approximately 31 months since first subject enrolled ]
    EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Lung Cancer Module (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the EORTC QLQ-C30
  • Progression-free survival (PFS) per RECIST v1.1 in all randomized participants [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, determined by CRAC per RECIST version 1.1, or death of any cause, whichever occurs first.
  • Overall survival (OS) in all randomized participants [ Time Frame: Approximately 31 months since first subject enrolled ]
    OS is defined as the number of months from randomization to death of any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Progression-free survival (PFS) based on investigator assessment [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, as assessed by the investigator per RECIST version 1.1, or death of any cause, whichever occurs first.
  • Objective response rate (ORR) per the CRAC [ Time Frame: Approximately 31 months since first subject enrolled ]
    ORR the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.
  • Clinical benefit rate (CBR) per the CRAC assessment [ Time Frame: Approximately 31 months since first subject enrolled ]
    CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.
  • CBR per the investigator assessment [ Time Frame: Approximately 31 months since first subject enrolled ]
    CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per investigator from the date of randomization until disease progression or death, whichever occurs first.
  • Duration of response (DOR) per the CRAC assessment [ Time Frame: Approximately 31 months since first subject enrolled ]
    DOR is the time from the initial objective response (CR/PR) by CRAC to disease progression or death, whichever occurs first.
  • DOR per the investigator assessment [ Time Frame: Approximately 31 months since first subject enrolled ]
    DOR is the time from the initial objective response (CR/PR) by investigator to disease progression by investigator or death, whichever occurs first.
  • Changes in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Approximately 31 months since first subject enrolled ]
    EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
  • Changes in EORTC Quality of Life Questionnaire Lung Cancer Module (QLQ-LC13) [ Time Frame: Approximately 31 months since first subject enrolled ]
    Lung Cancer Module (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the EORTC QLQ-C30
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)
Brief Summary This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Placebo for dexamethasone
    Placebo for administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
  • Drug: Placebo for rovalpituzumab tesirine
    Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
  • Drug: Rovalpituzumab tesirine
    Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
  • Drug: Dexamethasone
    Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Study Arms  ICMJE
  • Experimental: Rovalpituzumab tesirine/dexamethasone
    Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
    Interventions:
    • Drug: Rovalpituzumab tesirine
    • Drug: Dexamethasone
  • Experimental: Placebo
    Placebo q6 wk; omitting every third cycle
    Interventions:
    • Drug: Placebo for dexamethasone
    • Drug: Placebo for rovalpituzumab tesirine
Publications * Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
740
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 22, 2022
Estimated Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
  • Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
  • Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Participants must have adequate bone marrow, renal and hepatic function
  • Availability of archived or representative tumor material for assessment of DLL3 expression

Exclusion Criteria:

  • Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
  • Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
  • Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Austria,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Croatia,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Serbia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033511
Other Study ID Numbers  ICMJE M16-298
2016-003503-64 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2019

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