Actively Recruiting
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)
Led by Daiichi Sankyo · Updated on 2026-02-06
123
Participants Needed
58
Research Sites
127 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older
- Have confirmed diagnosis of extensive stage-small cell lung cancer requiring first-line therapy
- For Cohort 1: Completed 4 cycles of first-line induction therapy with carboplatin, etoposide, and atezolizumab and showing ongoing response or stable disease
- For Cohort 2: No prior treatment for extensive stage-small cell lung cancer
- For Cohort 2: Have at least one measurable lesion on CT or MRI
- For Cohort 2: Have at least one lesion suitable for core biopsy and agree to provide tissue samples
- Have an ECOG performance status of 0 or 1
- Have adequate organ and bone marrow function as specified in the study protocol
- Females of childbearing potential must not be pregnant, must not breastfeed during treatment and specified periods after, and agree to use effective contraception
- Males capable of fathering children must agree to use contraception and avoid donating sperm during and after treatment
- Willing and able to comply with study visits, treatment, tests, and restrictions
You will not qualify if you...
- Prior treatment with B7-H3 targeted agents including I-DXd
- Prior discontinuation of antibody-drug conjugates with exatecan derivatives due to toxicity
- Prior treatment with certain immunotherapies except atezolizumab for Cohort 1
- Inadequate washout period before enrollment
- Recent cerebrovascular or arterial thromboembolic events within 6 months
- Active or symptomatic brain metastases or related neurological complications
- Clinically significant corneal disease
- Uncontrolled or significant cardiovascular disease
- History or current interstitial lung disease or pneumonitis needing corticosteroids
- Severe pulmonary issues from other lung illnesses
- Chronic steroid use above specified doses except for certain conditions
- History of other malignancies within 5 years except specified exceptions
- History of bone marrow, stem cell, or organ transplant
- Unresolved side effects from prior cancer treatments
- History of severe allergic reactions to study drugs or similar antibodies
- Active uncontrolled infections including HIV, hepatitis B or C
- History of autoimmune disease
- Severe or uncontrolled systemic diseases
- Receipt of live vaccines within 30 days before study drug
- Pregnant or breastfeeding females
- Other medical, psychological, or social conditions that may affect safety or study results
- Factors preventing regular follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
University of Alabama -Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
David Geffen School of Medicine
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
5
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Advent Health Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Active, Not Recruiting
10
Regents of the University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
13
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
14
John Theurer Cancer Center At Hackensack Umc
Hackensack, New Jersey, United States, 07601
Actively Recruiting
15
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone
Mineola, New York, United States, 11501
Actively Recruiting
16
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
18
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
19
Montefiore Medical Center
New York, New York, United States, 10461
Actively Recruiting
20
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
21
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
22
Thomas Jefferson University Hospital - Central
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
23
Scri Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
24
Next Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
25
Northwest Cancer Specialists, P.C.-Vancouver
Vancouver, Washington, United States, 98684
Actively Recruiting
26
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
27
Hopital Albert Calmette - Chu Lille
Lille, France, 59037
Actively Recruiting
28
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
29
Hôpital de la Timone
Marseille, France, 13005
Actively Recruiting
30
Institut Curie - Site de Paris
Paris, France, 75005
Actively Recruiting
31
Hopital Tenon
Paris, France, 75020
Actively Recruiting
32
Chu Rennes - Hopital Pontchaillou
Rennes, France, 35000
Actively Recruiting
33
CHU Nantes - Hôpital Guillaume et René Laënnec
Saint-Herblain, France, 44805
Actively Recruiting
34
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
35
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
36
NHO Himeji Medical Center
Himeji-shi, Japan, 670-8520
Actively Recruiting
37
Kansai Medical University Hospital
Hirakata-shi, Japan, 573-1191
Actively Recruiting
38
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
39
The Cancer Institute Hospital of Jfcr
Kōtoku, Japan, 135-8550
Actively Recruiting
40
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto, Japan, 861-4193
Actively Recruiting
41
Shizuoka Cancer Center
Nagaizumi-cho, Japan, 411-8777
Actively Recruiting
42
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Actively Recruiting
43
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
44
Kindai University Hospital
Ōsaka-sayama, Japan, 589-8511
Actively Recruiting
45
Tokushima University Hospital
Tokushima, Japan, 770-8503
Actively Recruiting
46
Fujita Health University Hospital
Toyoake-shi, Japan, 470-1192
Actively Recruiting
47
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
48
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 8035
Actively Recruiting
49
Ico Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Actively Recruiting
50
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
51
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
52
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
53
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
54
Next Madrid
Madrid, Spain, 28223
Actively Recruiting
55
Hospital Regional Universitario de Malaga
Málaga, Spain, 29010
Actively Recruiting
56
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
57
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
58
Hospital Alvaro Cunqueiro
Vigo, Spain, 36312
Actively Recruiting
Research Team
(
(US) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
(
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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