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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Stemcentrx
Sponsor:
Information provided by (Responsible Party):
Stemcentrx
ClinicalTrials.gov Identifier:
NCT02674568
First received: January 29, 2016
Last updated: February 15, 2017
Last verified: February 2017
  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).

Condition Intervention Phase
Small Cell Lung Cancer
Drug: Rovalpituzumab tesirine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Stemcentrx:

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

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

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

Estimated Enrollment: 154
Study Start Date: January 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02674568

Contacts
Contact: SCRX001-002 Study Team scrx001-002@stemcentrx.com
Contact: John H M Mei john.mei@stemcentrx.com

  Show 69 Study Locations
Sponsors and Collaborators
Stemcentrx
Investigators
Study Director: Sreeni Yalamanchili, Pharm.D. Stemcentrx
  More Information

Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02674568     History of Changes
Other Study ID Numbers: SCRX001-002 
Study First Received: January 29, 2016
Last Updated: February 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stemcentrx:
SCLC
Small Cell Lung Cancer
DLL3
Relapsed
Refractory

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

ClinicalTrials.gov processed this record on February 24, 2017