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)
NCT ID: NCT06362252
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
123 participants
INTERVENTIONAL
2024-07-22
2026-12-30
Brief Summary
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Detailed Description
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The primary objective of this study is to evaluate the safety and tolerability of I-DXd in combination with atezolizumab with or without carboplatin by assessing treatment-emergent adverse events (TEAEs) and other safety parameters which will inform optimal dose selection of I-DXd in the combination regimens (Dose Optimization Part B) of this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)
Part A (Safety Run-in): Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
A 5-day surveillance period between each of the first 3 participants (up to a maximum of 9 participants) dosed is included as a safety measure.
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)
Part A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Carboplatin
Intravenous administration
Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)
Part A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Carboplatin
Intravenous administration
Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg)
Part B: Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only starting at Cycle 1 Day 1. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg)
Part B: Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only starting at Cycle 1 Day 1. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)
Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Carboplatin
Intravenous administration
Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)
Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of IL I-DXd induction therapy (12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×minIV Q3W) followed by maintenance therapy. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Carboplatin
Intravenous administration
Interventions
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Ifinatamab deruxtecan
Intravenous administration
Atezolizumab
Intravenous administration
Carboplatin
Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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University of Alabama -Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
David Geffen School of Medicine
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
John Theurer Cancer Center At Hackensack Umc
Hackensack, New Jersey, United States
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone
Mineola, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital - Central
Philadelphia, Pennsylvania, United States
Scri Oncology Partners
Nashville, Tennessee, United States
Next Virginia
Fairfax, Virginia, United States
Northwest Cancer Specialists, P.C.-Vancouver
Vancouver, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hopital Albert Calmette - Chu Lille
Lille, , France
Centre Léon Bérard
Lyon, , France
Assistance Publique-Hă"Pitaux de Marseille
Marseille, , France
Institut Curie - Site de Paris
Paris, , France
Hopital Tenon
Paris, , France
Chu Rennes - Hopital Pontchaillou
Rennes, , France
Chu Nantes - Hă"Pital Guillaume Et Renă Laă<Nnec
Saint-Herblain, , France
Hă"Pital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
NHO Himeji Medical Center
Himeji-shi, , Japan
Kansai Medical University Hospital
Hirakata-shi, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, , Japan
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto, , Japan
Shizuoka Cancer Center
Nagaizumi-cho, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
Tokushima University Hospital
Tokushima, , Japan
Fujita Health University Hospital
Toyoake-shi, , Japan
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Ico Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Ico L'Hospitalet - Hospital Duran I Reynals
L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Next Madrid
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Alvaro Cunqueiro
Vigo, , Spain
Countries
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Central Contacts
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(US) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
Facility Contacts
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Other Identifiers
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2023-509629-36
Identifier Type: OTHER
Identifier Source: secondary_id
2031240089
Identifier Type: OTHER
Identifier Source: secondary_id
DS7300-189
Identifier Type: -
Identifier Source: org_study_id
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