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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rovalpituzumab Tesirine

Rovalpituzumab Tesirine 0.3 mg/kg IV infusion

Group Type EXPERIMENTAL

Rovalpituzumab Tesirine

Intervention Type DRUG

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

Rovalpituzumab Tesirine followed by Cisplatin, Etoposide

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

Group Type EXPERIMENTAL

Rovalpituzumab Tesirine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Rovalpituzumab Tesirine with Cisplatin, Etoposide

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

Group Type EXPERIMENTAL

Rovalpituzumab Tesirine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Rovalpituzumab Tesirine following Cisplatin, Etoposide

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

Group Type EXPERIMENTAL

Rovalpituzumab Tesirine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Interventions

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Rovalpituzumab Tesirine

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

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Other Intervention Names

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SC16LD6.5

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No