Small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Rovalpituzumab tesirine
Product Code: SC16LD6.5
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ROVALPITUZUMAB
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be an age of 18 years or older, providing written informed consent 2) Histologically or cytologically confirmed advanced or metastatic SCLC with documented first disease progression after or during front-line platinum-based systemic regimen. 3) Tumor must have high DLL3 expression (DLL3high) defined as having > 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay. Archived or fresh tumor material can be used for the DLL3 testing. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5) Females of childbearing potential must have a negative serum pregnancy test result at Screening, and a negative urine pregnancy test at randomization. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile) at Screening do not require pregnancy testing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 206 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 205
Exclusion criteria
Exclusion criteria: 1) Any significant medical condition 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 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) Subject has known leptomeningeal metastases 4) Subject has Isolated CNS disease progression with no evidence of progression outside of CNS 5) Subject has more than one prior systemic therapy regimen for SCLC (prior systemic maintenance therapy following front-line platinum based regimen, administered as part of clinical trial is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess treatment with rovalpituzumab tesirine imrpoves objective response rate (ORR) and overall survival rate (OS) compared to topotecan in subjects with DLL3high SCLC who have first disease progression during or following front-line platinum based chemotherapy.; Secondary Objective: 1) Assess if treatment with rovalpituzumab tesirine improves progression free survivial (PFS) compared to topotecan in subjects with advanced or metastatic DLL3high SCLC who have first disease progression during or following front-line platinum based chemotherapy, 2) Compare the duration of object response between two arms, 3) To assess the pharmacokinetics (PK) and immunogenicity of rovalpituzumab tesirine, 4) Assess the effect on patient reported outcomes (i.e. health-related quality of life and symptom assessment) due to treatment with rovalpituzumab tesirine compared to topotecan in subects with DLL3high SCLC who have first disease progression during or following front-line platinum based chemotherapy. ; Primary end point(s): - Objective response rate (ORR) - Overall survival (OS) ; Timepoint(s) of evaluation of this end point: - Objective Response Rate will be performed in the response-evaluable set, defined as all randomized subjects with measureable disease at baseline who have had a minimum follow-up of 5 months at the time of analysis. - Overall Survival is defined as the time from the date of randomization to the date of death form any cause (i.e., date of subject's death - date of randomization +1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival (PFS) based on the CRAC per RECIST v1.1, - Duration of objective response (DOR) based on the CRAC per RECIST v1.1, - Patient reported outcomes (PROs). ; Timepoint(s) of evaluation of this end point: - PFS is based on independent review of tumor assessment, defined as the time from randomization to documented CRAC-assessed disease progression or death from any cause (whichever occurs earlier). - DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, whichever comes first. | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Latvia, Mexico, Netherlands, Poland, Portugal, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed