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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02674568
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Rovalpituzumab tesirine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Rovalpituzumab tesirine
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).
Drug: Rovalpituzumab tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
Other Name: SC16LD6.5

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 1.5 year ]
  2. Overall survival for subjects [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: 4 years ]
  2. Duration of Response [ Time Frame: 4 years ]
  3. Progression-free Survival [ Time Frame: 4 years ]

Other Outcome Measures:
  1. Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 4 years ]
  2. Number of subjects with treatment-related changes in vital signs from baseline [ Time Frame: 4 years ]
  3. Number of subjects with treatment-related laboratory abnormalities from baseline [ Time Frame: 4 years ]
  4. Number of subjects with treatment-related electrocardiographic intervals change from baseline [ Time Frame: 4 years ]
  5. Number of subjects with treatment-related electrocardiography parameters change from baseline [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (β-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02674568

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Sponsors and Collaborators
Study Director: Sreeni Yalamanchili, Pharm.D. Stemcentrx

Responsible Party: Stemcentrx Identifier: NCT02674568     History of Changes
Other Study ID Numbers: SCRX001-002
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stemcentrx:
Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms