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

Recruiting now · Phase 3

Conditions studied: Small Cell Lung Cancer

In brief

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).

Key facts

Study ID: NCT06203210
Run by: Daiichi Sankyo
People needed: 540
Starts: 2024-05-21
Expected to finish: 2029-12-01
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must meet all the following criteria to be eligible for randomization into the study:
Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
The participant 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 [CTFI] (duration from stop date of the platinum agent in 1L therapy to radiological PD) 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 less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1).
Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.

You may not qualify if…

Participants who meet any of the following criteria will be disqualified from entering the study:
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 (CV) disease.
Has clinically significant corneal disease.
All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded:
Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids.
Current diagnosis of ILD.
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.
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.

Where it is running

THE WEST CLINIC, PLLC dba West Cancer Center — Germantown, Tennessee, United States (enrolling)
University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
UCSF Mission Bay Mission Hall — San Francisco, California, United States (enrolling)
Clinical Research Providence Medical Foundation — Fullerton, California, United States (enrolling)
Houston Methodist Cancer Center — Houston, Texas, United States (enrolling)
UCLA Hematology-Oncology — Los Angeles, California, United States (enrolling)
Rush MD Anderson Cancer Center — Chicago, Illinois, United States (enrolling)
Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
AdventHealth Orlando, Cancer Institute — Orlando, Florida, United States (enrolling)
Mercy Clinic Oncology and Hematology Sindelar Cancer Center — St Louis, Missouri, United States (enrolling)
University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
Astera Cancer Care — East Brunswick, New Jersey, United States (enrolling)
Hackensack Meridian Health Jsumc — Neptune City, New Jersey, United States (enrolling)
Clinical Research Alliance, Inc — Lake Success, New York, United States (enrolling)
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island — New York, New York, United States (enrolling)
New York University Cancer Center - Laura and Isaac — New York, New York, United States (enrolling)
John Hopkins School of Medicine — Baltimore, Maryland, United States (enrolling)
Cleveland Clinic Mercy Hospital — Canton, Ohio, United States (enrolling)
Oncology/Hematology Care Clinical Trials, Llc — Cincinnati, Ohio, United States (enrolling)
Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
Texas Oncology, P.A. - Tyler — Tyler, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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