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Clinical Trials in the USA / NCT06203210
Recruiting Phase 3

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

NCT06203210 · tracked via the Priya Life Science USA tracker
Sponsor
Daiichi Sankyo
Phase
Phase 3
Started
2024-05-21
Last updated
2026-08-06

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Ifinatamab deruxtecanTopotecanAmrubicinLurbinectedin

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)

Trial sites (229)

FacilityCityRegionStatus
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.

More Daiichi Sankyo trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT06203210 on ClinicalTrials.gov ↗ ← All trials in the USA