Clinical Trials /

A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Extensive Stage Small Cell Lung Cancer

NCT02819999

Description:

The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Delta-Like Protein 3-Expressing Extensive Stage Small Cell Lung Cancer
  • Official Title: A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Delta-Like Protein 3-Expressing Extensive Stage Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: SCRX001-004
  • NCT ID: NCT02819999

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Rovalpituzumab TesirineSC16LD6.5Rovalpituzumab Tesirine
CisplatinRovalpituzumab Tesirine followed by Cisplatin, Etoposide
EtoposideRovalpituzumab Tesirine followed by Cisplatin, Etoposide

Purpose

The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).

Trial Arms

NameTypeDescriptionInterventions
Rovalpituzumab TesirineExperimentalRovalpituzumab Tesirine 0.3 mg/kg IV infusion
  • Rovalpituzumab Tesirine
Rovalpituzumab Tesirine followed by Cisplatin, EtoposideExperimentalRovalpituzumab Tesirine 0.3 mg/kg IV infusion followed by Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion
  • Rovalpituzumab Tesirine
  • Cisplatin
  • Etoposide
Rovalpituzumab Tesirine with Cisplatin, EtoposideExperimentalCisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion and Rovalpituzumab Tesirine 0.1 mg/kg IV infusion
  • Rovalpituzumab Tesirine
  • Cisplatin
  • Etoposide
Rovalpituzumab Tesirine following Cisplatin, EtoposideExperimentalCisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion followed by Rovalpituzumab Tesirine 0.3 mg/kg IV infusion
  • Rovalpituzumab Tesirine
  • Cisplatin
  • Etoposide

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage,
             chemotherapy-naïve SCLC

          -  DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive
             is defined as staining in ≥75% of tumor cells.

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

          -  Minimum life expectancy of at least 12 weeks.

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

          -  Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb,
             total bilirubin, ALT, AST and GFR)

          -  Subjects with a history of CNS metastases must have completed definitive treatment
             prior to first dose of study treatment, off or on a stable dose of corticosteroids

          -  Use of effective contraception method during and for 1 year following study drug
             dosing if female of childbearing potential or sexually active male

        Exclusion Criteria:

          -  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 anticancer therapy for the
             treatment of (limited or extensive) SCLC.

          -  Any significant medical condition, that, in the opinion of the investigator or
             sponsor, may place the subject at undue risk from the study.

          -  Documented history of a cerebral vascular, 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.

          -  Recent or ongoing serious infection.

          -  Women who are pregnant or breastfeeding.

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

          -  Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity
             to rovalpituzumab tesirine or excipient contained in the drug formulation
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with delta-like protein 3 (DLL3)-expressing extensive-stage small cell lung cancer (SCLC)
Time Frame:within 21 days after first dose of rovalpituzumab tesirine
Safety Issue:
Description:For Phase 1a

Secondary Outcome Measures

Measure:Best overall response rate
Time Frame:4 years
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:4 years
Safety Issue:
Description:
Measure:Clinical Benefit Rate (CBR)
Time Frame:4 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:4 years
Safety Issue:
Description:
Measure:Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine
Time Frame:4 years
Safety Issue:
Description:
Measure:Progression-free survival (Phase 1a)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: Cmax (Maximum plasma concentration observed )
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: AUC0-tau (Area under the plasma concentration-time curve within a dosing interval)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: AUC0-∞ (Area under the curve from time 0 extrapolated to infinity)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: Tmax (Time of Cmax)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: Ctrough (Observed plasma concentrations at trough)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: T1/2 (Terminal half-life)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: CL (Clearance)
Time Frame:4 years
Safety Issue:
Description:
Measure:Pharmacokinetic parameters: Vss (Volume of distribution at steady state)
Time Frame:4 years
Safety Issue:
Description:
Measure:Incidence of TEAEs
Time Frame:4 years
Safety Issue:
Description:For Phase 1b
Measure:Changes in vital signs (Heart Rate)
Time Frame:4 years
Safety Issue:
Description:
Measure:Changes in vital signs (Blood pressure)
Time Frame:4 years
Safety Issue:
Description:
Measure:Changes in vital signs (Temperature)
Time Frame:4 years
Safety Issue:
Description:
Measure:Changes in vital signs (Weight)
Time Frame:4 years
Safety Issue:
Description:
Measure:Changes in vital signs (Respirations)
Time Frame:4 years
Safety Issue:
Description:
Measure:Eastern Cooperative Oncology Group (ECOG) score
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Stemcentrx

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