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Clinical Trials in Spain / NCT06362252
Recruiting Phase 1/2

A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)

NCT06362252 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2024-07-22
Last updated
2026-02-06

Condition(s) studied

Extensive Stage-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Ifinatamab deruxtecan →Atezolizumab →Carboplatin →

Ifinatamab deruxtecan: Intravenous administration

Atezolizumab: Intravenous administration

Carboplatin: Intravenous administration

Study summary

This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
A full list of inclusion/exclusion criteria are available in the protocol. Inclusion Criteria Participants must meet all of the following criteria to be eligible for enrollment into the study: 1. Sign and date the informed consent form (ICF), 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 ICF is signed. 3. Has histologically or cytologically confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy. 4. For Cohort 1, participant has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR PR, CR, or SD per RECIST v1.1 assessed by the investigator. For Cohort 2, participant has received no prior treatment for ES-SCLC. 5. For Cohort 2, participant has at least one measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator. 6. For Cohort 2, participant must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy. 7. Has ECOG PS of ≤1 (assessed within 7 days before enrollment/randomization). 8. Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol. 9. A female subject of childbearing potential (POCBP) is eligible to participate if the following conditions are met: 1. Subject is not pregnant as confirmed by highly sensitive pregnancy test during Screening (within 3 days prior to enrollment/randomization) 2. Subject does not breastfeed during the treatment period and for at least 8/5/6 months after last dose of I-DXd/atezolizumab/carboplatin, respectively. 3. Subject agrees to adhere to a contraceptive method that is highly effective and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the treatment period and for at least the time needed to eliminate each study drug after the last dose. The length of time required to continue contraception and avoid donating/freezing eggs after last dose for I-DXd/atezolizumab/carboplatin is 8/5/6 months, respectively. Preservation of eggs may be considered prior to first dose of study drug. 10. A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd/atezolizumab/carboplatin is 6/5/6 months, respectively. 1. Avoid donating sperm. 2. Adhere to either of the contraception methods: true abstinence from penile-vaginal intercourse or uses a penile/external condom when having penile-vaginal intercourse with a non-subject of childbearing potential plus partner use of an additional contraceptive method. 11. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. 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-H3 targeted agents, including I-DXd. 2. Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities. 3. Has received prior treatment with CD137 agonists or ICIs, including anti-cytotoxic T-cell lymphocyte-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, except for atezolizumab for Cohort 1. 4. Has inadequate washout period before enrollment/randomization as specified in the study protocol. 5. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event. 6. Has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. 7. Has clinically significant corneal disease. 8. Has uncontrolled or significant cardiovascular disease,. 9. Has history of (non-infectious) ILD/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening. 10. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses 11. Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections. 12. Has history of malignancy other than SCLC within the 5 years prior to randomization/enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumors, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery. 13. Has history of allogeneic bone marrow, stem cell, or solid organ transplant. 14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline. 15. Has history of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies. 16. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. 17. Has active or uncontrolled human immunodeficiency virus (HIV) infection. 18. Has active or uncontrolled hepatitis B or C virus (HBV or HCV) infection. 19. Has history of autoimmune disease. 20. Has any evidence of severe or uncontrolled systemic diseases. 21. Has received a live vaccine within 30 days prior to the first dose of study drug. 22. Is a female who is pregnant or breastfeeding or planning to become pregnant. 23. Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results. 24. Has psychological, social, familial, or logistical factors that would prevent regular follow-up

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
University of Alabama -Birmingham Birmingham Alabama Recruiting
Mayo Clinic Arizona Phoenix Arizona Recruiting
David Geffen School of Medicine Los Angeles California Not Yet Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Mayo Clinic-Jacksonville Jacksonville Florida Recruiting
Advent Health Orlando Orlando Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois Recruiting
Henry Ford Hospital Detroit Michigan Active Not Recruiting
Regents of the University of Minnesota Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
John Theurer Cancer Center At Hackensack Umc Hackensack New Jersey Recruiting
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone Mineola New York Recruiting
NYU Langone Hospital - Long Island Mineola New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Columbia University Hervert Irving Comprehensive Cancer Center New York New York Recruiting
Montefiore Medical Center New York New York Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute Lancaster Pennsylvania Recruiting
University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania Recruiting
Thomas Jefferson University Hospital - Central Philadelphia Pennsylvania Recruiting
Scri Oncology Partners Nashville Tennessee Recruiting
Next Virginia Fairfax Virginia Recruiting
Northwest Cancer Specialists, P.C.-Vancouver Vancouver Washington Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Hopital Albert Calmette - Chu Lille Lille France Recruiting
Centre Léon Bérard Lyon France Recruiting
Hôpital de la Timone Marseille France Recruiting
Institut Curie - Site de Paris Paris France Recruiting
Hopital Tenon Paris France Recruiting
Chu Rennes - Hopital Pontchaillou Rennes France Recruiting
CHU Nantes - Hôpital Guillaume et René Laënnec Saint-Herblain France Recruiting
Hôpital Foch Suresnes France Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
NHO Himeji Medical Center Himeji-shi Japan Recruiting
Kansai Medical University Hospital Hirakata-shi Japan Recruiting
National Cancer Center Hospital East Kashiwa Japan Recruiting
The Cancer Institute Hospital of Jfcr Kōtoku Japan Recruiting
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital Kumamoto Japan Recruiting

+ 18 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Daiichi Sankyo trials in Spain

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 NCT06362252 on ClinicalTrials.gov ↗ ← All trials in Spain