A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC
- Conditions
- Small Cell Lung Cancer (SCLC)
- Registration Number
- 2023-509628-16-00
- Lead Sponsor
- Daiichi Sankyo Inc.
- Brief Summary
To compare the efficacy of I-DXd with that of standard of care (SoC) in participants with SCLC using objective response rate (ORR) and overall survival (OS).
- Detailed Description
The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 212
Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC.).
The subject must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy-free interval of ≥30 days.
Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
Has documentation of radiological disease progression on or after the most recent systemic therapy.
Has ECOG PS of ≤1 within 7 days before C1D1.
Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases based on history and physical examination. For subjects with evidence of brain or leptomeningeal disease, they may be eligible if condition has been treated and a lack of progression within 4 weeks prior to initiation of study drug has been radiologically documented. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.
Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
Has received any of the comparators used in this study or any topoisomerase I inhibitor.
Has inadequate washout period before randomization as specified in the protocol .
Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
Has uncontrolled or significant cardiovascular disease.
Has clinically significant corneal disease.
Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of randomization, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR): The percentage of participants who show a confirmed complete response (no detectable cancer) or confirmed partial response (reduced tumor size) as assessed by blinded independent central review. Objective Response Rate (ORR): The percentage of participants who show a confirmed complete response (no detectable cancer) or confirmed partial response (reduced tumor size) as assessed by blinded independent central review.
Overall Survival (OS): The time interval from the date of randomization to the date of death due to any cause. Overall Survival (OS): The time interval from the date of randomization to the date of death due to any cause.
- Secondary Outcome Measures
Name Time Method ORR as assessed by the investigator, progression-free survival, duration of response, disease control rate, time to response, PROs measures of health-related quality of life, adverse events, antidrug antibody prevalence, correlation of B7-H3 protein expression in tumor tissue with clinical outcomes, and PK. ORR as assessed by the investigator, progression-free survival, duration of response, disease control rate, time to response, PROs measures of health-related quality of life, adverse events, antidrug antibody prevalence, correlation of B7-H3 protein expression in tumor tissue with clinical outcomes, and PK.
Trial Locations
- Locations (230)
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Clinical Research Providence Medical Foundation
🇺🇸Fullerton, California, United States
UCLA Hematology-Oncology
🇺🇸Los Angeles, California, United States
UCSF Mission Bay Mission Hall
🇺🇸San Francisco, California, United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
AdventHealth Orlando, Cancer Institute
🇺🇸Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
🇺🇸Tampa, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Scroll for more (220 remaining)Highlands Oncology Group🇺🇸Springdale, Arkansas, United StatesPrincipal InvestigatorContact