Trial 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)
NCT ID:
NCT06362252
Condition:
Extensive Stage-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Atezolizumab
Conditions: Keywords:
Extensive stage-small cell lung cancer (ES-SCLC)
Ifinatamab deruxtecan
I-DXd
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ifinatamab deruxtecan
Description:
Intravenous administration
Arm group label:
Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 8 mg/kg)
Arm group label:
Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)
Arm group label:
Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)
Other name:
I-DXd
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Intravenous administration
Arm group label:
Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 8 mg/kg)
Arm group label:
Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)
Arm group label:
Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Intravenous administration
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 8 mg/kg)
Arm group label:
Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)
Arm group label:
Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Intravenous administration
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 12 mg/kg)
Arm group label:
Cohort 1, Part B: SoC Induction + Maintenance (I-DXd 8 mg/kg)
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.
Detailed description:
This study consists of two parts and two cohorts: Part A (Phase 1b; Safety Run-in) and
Part B (Phase 2; Dose Optimization), Cohort 1 (I-DXd in maintenance) and Cohort 2 (I-DXd
in induction + maintenance).
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.
Criteria for eligibility:
Criteria:
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 therapy.
4. For Cohort 1 Part A, 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.
5. For Cohort 1 Part B and Cohort 2, participant has received no prior treatment for
ES-SCLC.
5. For Cohort 1 Part B and 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 1 Part B and 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 function within 7 days before the start of study treatment as
specified in the study protocol.
9. If the participant is a female of childbearing potential, she must have a negative
serum pregnancy test during Screening (within 28 days prior to randomization). Male
and female participants of reproductive/childbearing potential must agree to use a
highly effective form of contraception or avoid intercourse during and upon
completion of the study and for at least 7 months for females and 4 months for males
after the last dose of study drug.
10. Male participants must not freeze or donate sperm starting at
enrollment/randomization, throughout the Treatment Period, and for at least 4 months
following the last dose of the study drug. Preservation of sperm may be considered
prior to enrollment/randomization.
11. Female participants must not donate, or retrieve for their own use, ova from the
time of enrollment/randomization and throughout the Treatment Period and for at
least 7 months following the last dose of the study drug.
12. 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 (CTLA-4), anti-PD-1, and anti-PD-L1 therapeutic antibodies,
except for atezolizumab for Cohort 1 Part A.
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 known human immunodeficiency virus (HIV) infection that is not well controlled.
18. Has active or uncontrolled hepatitis B or C 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama -Birmingham
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
David Geffen School of Medicine
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hoag Memorial Hospital Presbyterian
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Mayo Clinic-Jacksonville
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Adventhealth Orlando
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Regents of the University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Dartmouth-Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03766
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
John Theurer Cancer Center At Hackensack Umc
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
NYU Langone Hospital - Long Island
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Columbia University Hervert Irving Comprehensive Cancer Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Thomas Jefferson University Hospital - Central
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Scri Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Next Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Northwest Cancer Specialists, P.C.-Vancouver
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hopital Albert Calmette - Chu Lille
Address:
City:
Lille Cedex
Zip:
59037
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Assistance Publique-Hăpitaux de Marseille
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Curie - Site de Paris
Address:
City:
Paris Cedex 05
Zip:
75005
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hopital Tenon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Chu Rennes - Hopital Pontchaillou
Address:
City:
Rennes cedex 09
Zip:
35000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Chu Nantes - Hăpital Guillaume Et Renă Laănnec
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hăpital Foch
Address:
City:
Suresnes Cedex
Zip:
92151
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata-shi
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
The Cancer Institute Hospital of Jfcr
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Address:
City:
Kumamoto
Zip:
861-4193
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kindai University Hospital
Address:
City:
Osaka-Sayama
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall D'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ico Girona - Hospital Universitari de Girona Dr Josep Trueta
Address:
City:
Girona
Zip:
17007
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ico L'Hospitalet - Hospital Duran I Reynals
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramon Y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Regional Universitario de Malaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Next Madrid
Address:
City:
Pozuelo De AlarcĂłn
Zip:
28223
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Alvaro Cunqueiro
Address:
City:
Vigo
Zip:
36312
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Start date:
July 22, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06362252
