Small Cell Lung Cancer
Conditions
Keywords
Cancer, Small Cell Lung Cancer, Relapsed Small Cell Lung Cancer, Remitting Small Cell Lung Cancer, Delta-like protein 3 (DLL3), DLL3 Expressing Small Cell Lung Cancer, Rovalpituzumab Tesirine
Brief summary
A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (\>= Grade 3) select treatment-emergent adverse events (TEAEs).
Interventions
DRUGDexamethasone
Oral
Intravenous
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Minimum life expectancy of at least 12 weeks. * Laboratory values meeting the criteria specified in the protocol. * Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen. * Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue. * Measurable disease as described per protocol. * In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids.
Exclusion criteria
* 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 Class III - IV within 6 months prior to first dose of study drug. * Recent or on-going serious infection. * History of other invasive malignancy that has not been in remission for at least 3 years. * History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation. * Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells. * Documented history of capillary leak syndrome. * Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE | Approximately 32 months | Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant Reported Outcome EORTC QLQC15-PAL | Approximately 32 months | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical & emotional functioning, fatigue and pain) along with 6 individual items (nausea & vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life). |
| Overall Survival (OS) | Approximately 32 months | Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause. |
| Objective response rate (ORR) | Approximately 32 months | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Progression Free Survival (PFS) | Approximately 32 months | PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier. |
| Duration of Objective Response (DOR) | Approximately 32 months | 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 version 1.1) or death due to any cause, whichever comes first. |
| Clinical Benefit Rate (CBR) | Approximately 32 months | CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1. |
| Change in EORTC QLQ-LC-13 | Approximately 32 months | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients. |
Countries
Australia, Brazil, Canada, Germany, Sweden, United Kingdom, United States
Outcome results
None listed