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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02819999
• Other study ID #: SCRX001-004
• Status: Terminated
• Phase: Phase 1
• Start date: October 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
• Cisplatin

• Etoposide

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospital of Cleveland	Cleveland	Ohio
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Texas Oncology	Fort Worth	Texas
United States	Cancer Institute of Florida	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Texas Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with DLL3 expressing extensive-stage small cell lung cancer (SCLC)	For Phase 1a	within 21 days after first dose of rovalpituzumab tesirine
Primary	Treatment emergent adverse events (TEAEs)	For Phase 1a	through 30 days after last dose of study treatment
Primary	Incidence of subjects with CTCAE Grade >2 laboratory abnormalities	For Phase 1a	through 30 days after last dose of study treatment
Primary	Progression-Free Survival (PFS)	For Phase 1b	4 years
Secondary	Best overall response rate		4 years
Secondary	Duration of response (DOR)		4 years
Secondary	Clinical Benefit Rate (CBR)		4 years
Secondary	Overall Survival (OS)		4 years
Secondary	Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine		4 years
Secondary	Progression-free survival (Phase 1a)		4 years
Secondary	Pharmacokinetic parameters: Cmax (Maximum plasma concentration observed )		4 years
Secondary	Pharmacokinetic parameters: AUC0-tau (Area under the plasma concentration-time curve within a dosing interval)		4 years
Secondary	Pharmacokinetic parameters: AUC0-8 (Area under the curve from time 0 extrapolated to infinity)		4 years
Secondary	Pharmacokinetic parameters: Tmax (Time of Cmax)		4 years
Secondary	Pharmacokinetic parameters: Ctrough (Observed plasma concentrations at trough)		4 years
Secondary	Pharmacokinetic parameters: T1/2 (Terminal half-life)		4 years
Secondary	Pharmacokinetic parameters: CL (Clearance)		4 years
Secondary	Pharmacokinetic parameters: Vss (Volume of distribution at steady state)		4 years
Secondary	Incidence of TEAEs	For Phase 1b	4 years
Secondary	Changes in vital signs (Heart Rate)		4 years
Secondary	Changes in vital signs (Blood pressure)		4 years
Secondary	Changes in vital signs (Temperature)		4 years
Secondary	Changes in vital signs (Weight)		4 years
Secondary	Changes in vital signs (Respirations)		4 years
Secondary	Eastern Cooperative Oncology Group (ECOG) score		4 years