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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Oral
Intravenous
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
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.
Time frame: Approximately 32 months
Change in Participant Reported Outcome EORTC QLQC15-PAL
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).
Time frame: Approximately 32 months
Progression Free Survival (PFS)
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.
Time frame: Approximately 32 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Time frame: Approximately 32 months
Objective response rate (ORR)
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.
Time frame: Approximately 32 months
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Ironwood Cancer & Res Ctr /ID# 171335
Chandler, Arizona, United States
Mayo Clinic - Scottsdale /ID# 171359
Scottsdale, Arizona, United States
VA Central California Health C /ID# 170951
Fresno, California, United States
Loma Linda University Medical /ID# 171377
Loma Linda, California, United States
UC Irvine Health /ID# 171343
Orange, California, United States
Kaiser Permanente - Roseville /ID# 200779
Roseville, California, United States
Kaiser Permanente-Santa Clara /ID# 203024
Santa Clara, California, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
Vallejo, California, United States
Kaiser Permanente- Walnut Creek /ID# 201305
Walnut Creek, California, United States
Univ of Colorado Cancer Center /ID# 200810
Aurora, Colorado, United States
...and 50 more locations
Change in EORTC QLQ-LC-13
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.
Time frame: Approximately 32 months
Duration of Objective Response (DOR)
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.
Time frame: Approximately 32 months
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.
Time frame: Approximately 32 months