Loading clinical trials...

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

NCT06203210•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study was 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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 prior to the start of any study-specific qualification procedures.
•2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form 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 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 ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
•9. Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system \[CNS\] metastases) based on history and physical examination. 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.
+2 more criteria

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 disease.
•7. Has clinically significant corneal disease.

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 MD Anderson Cancer Center

Chicago, Illinois, United States

Baptist Health Lexington

Lexington, Kentucky, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

May 21, 2024

Primary Completion Date

April 30, 2027

Completion Date

February 22, 2029

Last Updated

March 2, 2026

Enrollment

540

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

Ifinatamab deruxtecan

DRUG

Topotecan

DRUG

Amrubicin

DRUG

Lurbinectedin

DRUG

Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

9089926400 CTRinfo@dsi.com

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)