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

NCT02819999 | Terminated Phase 1

• 1 other identifier: SCRX001-004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• Treatment emergent adverse events (TEAEs)

  For Phase 1a

  through 30 days after last dose of study treatment

• Incidence of subjects with CTCAE Grade >2 laboratory abnormalities

  For Phase 1a

  through 30 days after last dose of study treatment

• Progression-Free Survival (PFS)

  For Phase 1b

  4 years

Secondary Outcomes (21)

• Best overall response rate

  4 years

• Duration of response (DOR)

  4 years

• Clinical Benefit Rate (CBR)

  4 years

• Overall Survival (OS)

  4 years

• Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine

  4 years

Study Arms (4)

Rovalpituzumab Tesirine

EXPERIMENTAL

Rovalpituzumab Tesirine 0.3 mg/kg IV infusion

Drug: Rovalpituzumab Tesirine

Rovalpituzumab Tesirine followed by Cisplatin, Etoposide

EXPERIMENTAL

Rovalpituzumab Tesirine 0.3 mg/kg IV infusion followed by Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion

Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide

Rovalpituzumab Tesirine with Cisplatin, Etoposide

EXPERIMENTAL

Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion and Rovalpituzumab Tesirine 0.1 mg/kg IV infusion

Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide

Rovalpituzumab Tesirine following Cisplatin, Etoposide

EXPERIMENTAL

Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion followed by Rovalpituzumab Tesirine 0.3 mg/kg IV infusion

Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide

Interventions

Rovalpituzumab Tesirine DRUG

Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).

Also known as: SC16LD6.5

Rovalpituzumab Tesirine; Rovalpituzumab Tesirine followed by Cisplatin, Etoposide; Rovalpituzumab Tesirine following Cisplatin, Etoposide; Rovalpituzumab Tesirine with Cisplatin, Etoposide

Cisplatin DRUG

Rovalpituzumab Tesirine followed by Cisplatin, Etoposide; Rovalpituzumab Tesirine following Cisplatin, Etoposide; Rovalpituzumab Tesirine with Cisplatin, Etoposide

Etoposide DRUG

Rovalpituzumab Tesirine followed by Cisplatin, Etoposide; Rovalpituzumab Tesirine following Cisplatin, Etoposide; Rovalpituzumab Tesirine with Cisplatin, Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (11)

University of Colorado

Aurora, Colorado, 80010, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Cancer Institute of Florida

Orlando, Florida, 32804, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

University Hospital of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

Texas Oncology

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

rovalpituzumab tesirine; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 30, 2016
• Study Start: October 1, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: March 12, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)