Clinical Trials /

Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)

NCT02674568

Description:

The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a third-line and later treatment for subjects with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC).

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)

Title

  • Brief Title: Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)
  • Official Title: An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)
  • Clinical Trial IDs

    NCT ID: NCT02674568

    ORG ID: SCRX001-002

    Trial Conditions

    Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Rovalpituzumab tesirine SC16LD6.5 Rovalpituzumab tesirine

    Trial Purpose

    The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a
    third-line and later treatment for subjects with relapsed or refractory delta-like protein 3
    (DLL3) expressing small cell lung cancer (SCLC).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Rovalpituzumab tesirine Experimental Subjects will be dosed with rovalpituzumab tesirine intravenously on Day 1 of each 6 week cycle for 2 cycles follow by end of treatment visit and long term follow-ups. Eligible subjects may qualify for retreatment (additional treatment). Rovalpituzumab tesirine

    Eligibility Criteria

    Inclusion Criteria:

    1. Adult aged 18 years or older

    2. Histologically confirmed small-cell lung cancer (SCLC) with documented disease
    progression after at least 2 prior systemic regimens, including at least one
    platinum-based regimen

    3. DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked
    or otherwise representative tumor tissue. Positive is defined as staining in 1% of
    tumor cells.

    4. Measurable disease as defined by RECIST 1.1

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

    6. Minimum life expectancy of at least 12 weeks

    7. Subjects with a history of central nervous system (CNS) metastases must have
    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.

    8. Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior
    to initiation of study drug administration

    9. Adequate hematologic and organ function as confirmed by laboratory values

    10. Last dose of any prior therapy administered by the following time intervals before
    the first dose of study drug:

    - Chemotherapy, small molecule inhibitors, radiation, and/or other investigational
    anticancer agents (excluding investigational monoclonal antibodies): 2 weeks

    - Immune-checkpoint inhibitors (i.e., anti-PD-1, anti-PD-L1, or anti-CTLA-4): 4
    weeks

    - Other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or
    T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease
    progression)

    11. Females of childbearing potential must have a negative beta human chorionic
    gonadotropin (-hCG) pregnancy test result within 7 days prior to the first dose of
    study drug. Females of non-childbearing potential are those who are postmenopausal
    greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

    Exclusion Criteria:

    1. Any significant medical condition, including any suggested by screening laboratory
    findings that, in the opinion of the investigator or sponsor, may place the subject
    at undue risk from the study, including but not necessarily limited to uncontrolled
    hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic
    obstructive pulmonary disease requiring hospitalization within 6 months) or
    neurological disorder (e.g., seizure disorder active within 6 months)

    2. 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 (NYHA) Class III-IV within 6 months prior to their first
    dose of study drug

    3. Recent or ongoing serious infection, including:

    - Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or
    fungal infection within 2 weeks of the first dose of the study drug. Routine
    antimicrobial prophylaxis is permitted.

    - Known seropositivity for or active infection by human immunodeficiency virus
    (HIV)

    - Active Hepatitis B (by surface antigen expression or polymerase chain reaction)
    or C (by polymerase chain reaction) infection or on hepatitis-related antiviral
    therapy within 6 months of first dose of study drug.

    4. Women who are breastfeeding

    5. Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1
    week prior to the first dose of study drug

    6. History of another invasive malignancy that has not been in remission for at least 3
    years. Exceptions to the 3 year limit include nonmelanoma skin cancer, curatively
    treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous
    intraepithelial lesion on PAP smear

    7. Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity
    to rovalpituzumab tesirine or excipient contained in the drug formulation, unless
    undergoing retreatment with rovalpituzumab tesirine in the context of this protocol

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Objective response rate

    Overall survival for subjects

    Secondary Outcome Measures

    Clinical Benefit Rate

    Duration of Response

    Progression-free Survival

    Trial Keywords

    SCLC

    Small Cell Lung Cancer

    DLL3

    Relapsed

    Refractory