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Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

NCT03334487

Description:

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs).

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
  • Official Title: Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: M16-292
  • SECONDARY ID: 2017-003173-33
  • NCT ID: NCT03334487

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
DexamethasoneRovalpituzumab tesirine + dexamethasone
Rovalpituzumab tesirineSC16LD6.5Rovalpituzumab tesirine + dexamethasone

Purpose

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs).

Trial Arms

NameTypeDescriptionInterventions
Rovalpituzumab tesirine + dexamethasoneExperimentalRovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
  • Dexamethasone
  • Rovalpituzumab tesirine

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Minimum life expectancy of at least 12 weeks.

          -  Laboratory values meeting the criteria specified in the protocol.

          -  Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with
             documented disease progression after at least 2 prior systemic regimens, including at
             least one platinum-based regimen.

          -  Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry
             (IHC) assessment of banked or otherwise representative tumor tissue.

          -  Measurable disease as described per protocol.

          -  In participants with a history of central nervous system (CNS) metastases,
             documentation of stable or improved status based on brain imaging for at least 2 weeks
             after completion of definitive treatment and within 2 weeks prior to first dose of
             study drug, off or on a stable dose of corticosteroids.

        Exclusion Criteria:

          -  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 III - IV within 6 months prior to first dose of study drug.

          -  Recent or on-going serious infection.

          -  History of other invasive malignancy that has not been in remission for at least 3
             years.

          -  History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known
             hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug
             formulation.

          -  Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.

          -  Documented history of capillary leak syndrome.

          -  Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational
             drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing
             requirements for pericardiocentesis or thoracentesis.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
Time Frame:Approximately 32 months
Safety Issue:
Description:Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.

Secondary Outcome Measures

Measure:Change in Participant Reported Outcome EORTC QLQC15-PAL
Time Frame:Approximately 32 months
Safety Issue:
Description:The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical & emotional functioning, fatigue and pain) along with 6 individual items (nausea & vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life).
Measure:Progression Free Survival (PFS)
Time Frame:Approximately 32 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:Overall Survival (OS)
Time Frame:Approximately 32 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.
Measure:Objective response rate (ORR)
Time Frame:Approximately 32 months
Safety Issue:
Description: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.
Measure:Change in EORTC QLQ-LC-13
Time Frame:Approximately 32 months
Safety Issue:
Description:The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients.
Measure:Duration of Objective Response (DOR)
Time Frame:Approximately 32 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.
Measure:Clinical Benefit Rate (CBR)
Time Frame:Approximately 32 months
Safety Issue:
Description:CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.

Details

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

Trial Keywords

  • Cancer
  • Small Cell Lung Cancer
  • Relapsed Small Cell Lung Cancer
  • Remitting Small Cell Lung Cancer
  • Delta-like protein 3 (DLL3)
  • DLL3 Expressing Small Cell Lung Cancer
  • Rovalpituzumab Tesirine

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