Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT03334487|
Recruitment Status : Withdrawn (Strategic considerations)
First Posted : November 7, 2017
Last Update Posted : December 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Dexamethasone Drug: Rovalpituzumab tesirine||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer|
|Actual Study Start Date :||March 15, 2018|
|Actual Primary Completion Date :||December 20, 2018|
|Actual Study Completion Date :||December 20, 2018|
Experimental: Rovalpituzumab tesirine + dexamethasone
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
Drug: Rovalpituzumab tesirine
Other Name: SC16LD6.5
- Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE [ Time Frame: 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.
- Change in Participant Reported Outcome EORTC QLQC15-PAL [ Time Frame: 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).
- Progression Free Survival (PFS) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 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) [ Time Frame: 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.
- Change in EORTC QLQ-LC-13 [ Time Frame: 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.
- Duration of Objective Response (DOR) [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334487
|Study Director:||AbbVie Inc.||AbbVie|