Ifinatamab deruxtecan: 12 mg/kg intravenous dose on Day 1 of each 21-day cycle
Topotecan: Topotecan will be administered per local standard-of-care (SoC)
Amrubicin: Amrubicin will be administered per local SoC
Lurbinectedin: Lurbinectedin will be administered per local SoC
Study summary
This study is designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
Participants must meet all the following criteria to be eligible for randomization into the study:
1. Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
2. Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
5. 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 \[CTFI\] (duration from stop date of the platinum agent in 1L therapy to radiological PD) of ≥30 days.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
7. Has documentation of radiological disease progression on or after the most recent systemic therapy.
8. Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1).
9. Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.
Exclusion Criteria
Participants who meet any of the following criteria will be disqualified from entering the study:
1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.
4. Has inadequate washout period before randomization as specified in the protocol.
5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
6. Has uncontrolled or significant cardiovascular (CV) disease.
7. Has clinically significant corneal disease.
8. All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded:
1. Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids.
2. Current diagnosis of ILD.
3. Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and/or interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization.
9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.
Primary outcome measure(s)
Overall Survival (OS) — From the date of randomization to the date of death due to any cause, up to approximately 3.7 years OS is defined as the time interval from the date of randomization to the date of death due to any cause.
Trial sites (229)
Facility
City
Region
Status
Highlands Oncology Group
Springdale
Arkansas
Recruiting
Clinical Research Providence Medical Foundation
Fullerton
California
Recruiting
UCLA Hematology-Oncology
Los Angeles
California
Recruiting
UCSF Mission Bay Mission Hall
San Francisco
California
Recruiting
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami
Florida
Recruiting
AdventHealth Orlando, Cancer Institute
Orlando
Florida
Recruiting
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa
Florida
Not Yet Recruiting
Rush MD Anderson Cancer Center
Chicago
Illinois
Recruiting
Baptist Health Lexington
Lexington
Kentucky
Recruiting
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore
Maryland
Recruiting
John Hopkins School of Medicine
Baltimore
Maryland
Recruiting
Dana-Farber Cancer Institute
Boston
Massachusetts
Recruiting
Henry Ford Health System
Detroit
Michigan
Not Yet Recruiting
Mercy Clinic Oncology and Hematology Sindelar Cancer Center
St Louis
Missouri
Recruiting
University of Nebraska Medical Center
Omaha
Nebraska
Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
Recruiting
Astera Cancer Care
East Brunswick
New Jersey
Recruiting
Hackensack Meridian Health Jsumc
Neptune City
New Jersey
Recruiting
Clinical Research Alliance, Inc
Lake Success
New York
Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island
New York
New York
Recruiting
New York University Cancer Center - Laura and Isaac
New York
New York
Recruiting
Montefiore Medical Center Prime
The Bronx
New York
Not Yet Recruiting
Cleveland Clinic Mercy Hospital
Canton
Ohio
Recruiting
Oncology/Hematology Care Clinical Trials, Llc
Cincinnati
Ohio
Recruiting
Providence Portland Medical Center
Portland
Oregon
Not Yet Recruiting
THE WEST CLINIC, PLLC dba West Cancer Center
Germantown
Tennessee
Recruiting
Houston Methodist Cancer Center
Houston
Texas
Recruiting
University of Texas Md Anderson Cancer Center
Houston
Texas
Recruiting
Texas Oncology, P.A. - Tyler
Tyler
Texas
Recruiting
Medical College of Wisconsin
Milwaukee
Wisconsin
Not Yet Recruiting
Ballarat Base Hospital
Ballarat
Australia
Recruiting
Flinders Medical Centre (Fmc)
Bedford Park
Australia
Recruiting
Chris O Brien Lifehouse
Camperdown
Australia
Recruiting
Sunshine Hospital
St Albans
Australia
Recruiting
St John of God Subiaco Hospital
Subiaco
Australia
Recruiting
Townsville Cancer Centre
Townsville
Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba
Australia
Recruiting
Landeskrankenhaus Feldkirch
Feldkirch
Austria
Recruiting
Landesklinikum Krems
Krems
Austria
Recruiting
Kepler University Hospital
Linz
Austria
Recruiting
+ 189 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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