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JOURNAL ONKOLOGIE – STUDIE
IDeate-Lung01

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Rekrutierend

NCT-Nummer:
NCT05280470

Studienbeginn:
März 2022

Letztes Update:
09.04.2024

Wirkstoff:
Ifinatamab Deruxtecan (I-DXd)

Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Daiichi Sankyo

Collaborator:
Merck Sharp & Dohme LLC

Studienleiter

Global Clinical Leader
Study Director
Daiichi Sankyo

Kontakt

(US contact) Daiichi Sankyo Contact for Clinical Trial Information
Kontakt:
Phone: 908-992-6400
E-Mail: CTRinfo@dsi.com» Kontaktdaten anzeigen
Daiichi Sankyo Contact for Clinical Trial Information
Kontakt:
Phone: +81-3-6225-1111(M-F 9-5 JST)
E-Mail: dsclinicaltrial@daiichisankyo.co.jp» Kontaktdaten anzeigen

Studienlocations
(3 von 110)

Evangelische Lungenklinik Berlin
13125 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Carl-Gustav-Carus
1307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Highlands Oncology Group
72762 Springdale
United StatesRekrutierend» Google-Maps
The Cancer Specialists, Llc
32256 Jacksonville
United StatesRekrutierend» Google-Maps
H. Lee Moffitt Cancer Center and Research Institute
33612 Tampa
United StatesNoch nicht rekrutierend» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-Maps
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
21287 Baltimore
United StatesRekrutierend» Google-Maps
Dana-Faeber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
Cancer and Hematology Centers of Western Michigan
49503 Grand Rapids
United StatesRekrutierend» Google-Maps
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Hackensack Meridian Health-Southern Ocean Medical Center
08050 Manahawkin
United StatesRekrutierend» Google-Maps
Montefiore Medical Center Prime
10461 Bronx
United StatesRekrutierend» Google-Maps
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
10065 New York
United StatesRekrutierend» Google-Maps
Duke University Health System
27703 Durham
United StatesRekrutierend» Google-Maps
Sarah Cannon (Tennessee Oncology - Nashville)
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Millennium Physicians Association, Llp
77090 Houston
United StatesRekrutierend» Google-Maps
University of Washington Medical Center
98195 Seattle
United StatesRekrutierend» Google-Maps
University of Wisconsin Carbone Cancer Center
53705 Madison
United StatesNoch nicht rekrutierend» Google-Maps
Krankenhaus Nord - Wien
1210 Wien
AustriaNoch nicht rekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
Guangdong Provincial People'S Hospital
510000 Guangdong
ChinaRekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200032 Shanghai
ChinaRekrutierend» Google-Maps
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
430022 Wuhan
ChinaRekrutierend» Google-Maps
Centre Hospitalier Intercommunal de Créteil
94000 Créteil
FranceRekrutierend» Google-Maps
Hôpital Nord - Chu Marseille
13915 Marseille cedex 20
FranceRekrutierend» Google-Maps
Hopital Arnaud de Villeneuve
34295 Montpellier cedex 05
FranceRekrutierend» Google-Maps
Institut Curie - Site de Paris
75005 Paris Cedex 05
FranceRekrutierend» Google-Maps
Centre hospitalier Intercommunal de Créteil
94000 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of Jfcr
135-8550 Koto-ku
JapanRekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osaka-Sayama
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
National Cancer Center
10408 Goyan-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruña
15006 A Coruña
SpainRekrutierend» Google-Maps
Hospital Universitario Vall Dhebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Ico L'Hospitalet - Hospital Duran I Reynals
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon Y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario Malaga
29011 Malaga
SpainRekrutierend» Google-Maps
Chang Gung Medical Foundation - Kaohsiung Branch
83301 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital
40705 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taichung Veterans General Hospital
40705 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital Nckuh
704 Tainan
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
100225 Taipei City
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Hospital Linkou
333 Taoyuan
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This study will consist of 2 parts: dose optimization (Part 1) and extension (Part 2). In the

dose optimization part of the study (Part 1), approximately 80 participants with at least 1

prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy will be

enrolled. Two I-DXd doses will be tested (8 mg/kg Q3W and 12 mg/kg Q3W). In the extension

part of the study (Part 2), approximately 70 participants with a minimum of two previous

lines of systemic therapy will be enrolled. I-DXd will be administered at the selected dose

of 12 mg/kg Q3W.

In Part 1, eligible participants will be randomized in a 1:1 ratio to receive one of the two

dose levels of I-DXd. Randomization will be stratified by:

1. Prior receipt or of an anti-programmed death-ligand 1 (PD-[L]1) antibody (yes/no)

2. The chemotherapy-free interval (CTFI) from completion of the first-line therapy to the

date of documented radiological Progressive Disease of <90 days vs. ≥90 days in

second-line participants as well as the number of lines of therapy. Thus, the

stratification factor includes three categories: (1) second-line participants with CTFI

<90 days, (2) second-line participants with CTFI ≥90 days, and (3) third- and

fourth-line participants.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Participants must meet all the following criteria to be eligible for enrollment into the

study:

- Sign and date the informed consent form (ICF) prior to the start of any study-specific

qualification procedures.

- Participant must have at least one lesion, not previously irradiated, amenable to core

biopsy.

- Male or female subjects aged ≥18 years (follow local regulatory requirements if the

legal age of consent for study participation is >18 years old).

- Histologically or cytologically documented ES-SCLC.

- At least one measurable lesion according to RECIST v1.1 as assessed by the

investigator.

- Prior therapy with at least one platinum-based line as systemic therapy for

extensive-stage disease with at least two cycles of therapy (except in the case of

early objective PD) and beginning with protocol version 3.0, a minimum of two previous

lines of systemic therapy.

- Documentation of radiological disease progression on or after most recent systemic

therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion Criteria:

Participants who meet any of the following criteria will be disqualified from entering the

study:

- Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents,

including I-DXd.

- Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan

derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.

- Clinically active brain metastases, spinal cord compression or leptomeningeal

carcinomatosis, defined as untreated or symptomatic, or requiring therapy with

steroids or anticonvulsants to control associated symptoms.

- Any of the following conditions within the past 6 months: cerebrovascular accident,

transient ischemic attack, or another arterial thromboembolic event.

- Clinically significant corneal disease.

- Uncontrolled or significant cardiovascular disease.

- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required

corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be

ruled out by imaging at screening.

- Clinically severe pulmonary compromise resulting from intercurrent pulmonary

illnesses,

- Chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except

for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin

conditions) or intra-articular steroid injections.

- History of malignancy other than SCLC within the 3 years prior to enrollment, except

adequately resected non-melanoma skin cancer, curatively treated in situ disease,

superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer

curatively resected by endoscopic surgery.

- History of allogeneic bone marrow, stem cell, or solid organ transplant.

- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other

than alopecia) not yet resolved to National Cancer Institute- Common Terminology

Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade ≤1 or baseline.

- History of hypersensitivity to the drug substances, inactive ingredients in the drug

product or severe hypersensitivity reactions to other monoclonal antibodies.

- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.

- Has active or uncontrolled hepatitis B or C infection.

- Active, known, or suspected autoimmune disease.

- Any evidence of severe or uncontrolled systemic diseases (including active bleeding

diatheses, psychiatric illness/social situations, substance abuse).

- Has received a live vaccine within 30 days prior to the first dose of study drug.

- Female who is pregnant or breast-feeding or intends to become pregnant during the

study.

- 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.

- Known human immunodeficiency virus (HIV) infection that is not well controlled.

Studien-Rationale

Primary outcome:

1. Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Up to approximately 36 months):
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR based on RECIST version 1.1. For all target, non-target, and new lesions, CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of all lesions.



Secondary outcome:

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Up to approximately 36 months):
TEAEs are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.

2. Progression-Free Survival (PFS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months):
PFS is defined as the time interval from the date of enrollment to the date of disease progression based on RECIST v1.1 or death due to any cause. PFS will be assessed by BICR and investigator.

3. Duration of Response (DoR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months):
DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression based on RECIST v1.1 or to death due to any cause, whichever occurs first. DoR will be assessed by BICR and investigator.

4. Overall Survival (OS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - From enrollment until death, up to approximately 36 months):
OS is defined as the time interval from the date of enrollment to the date of death due to any cause or last contact follow-up, whichever occurs first.

5. Time to Response (TTR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months):
TTR is defined as the time from the date of enrollment to the first documentation of objective tumor response (CR or PR) based on RECIST v.1.1. TTR will be assessed by BICR and investigator.

6. Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Up to approximately 36 months):
ORR was the defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator based on RECIST version 1.1. For all target, non-target, and new lesions, CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of all lesions.

7. Disease Control Rate (DCR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Up to approximately 36 months):
DCR is defined as percentage of participants with BOR of CR, PR, or stable disease, according to RECIST v1.1.

8. Maximum Plasma Concentration (Cmax) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)):
Cmax will be calculated using noncompartmental methods. Cmax will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.

9. Time to Reach Maximum Serum Concentration (Tmax) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)):
Tmax will be calculated using noncompartmental methods. Tmax will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.

10. Minimum Observed Concentration (Ctrough) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)):
Ctrough will be calculated using noncompartmental methods. Ctrough will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.

11. Area Under the Curve (AUC) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)):
AUC will be calculated using noncompartmental methods. AUC will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.

12. Terminal Half-Life (T1/2) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)):
T1/2 will be calculated using noncompartmental methods. T1/2 will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.

13. Percentage of Participants Who Have Treatment-Emergent Antidrug Antibodies (ADA) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (Time Frame - Cycle 1, Cycle 2, Cycle 3 and Cycle 4 Day 1: Predose; Cycle 5 Day 1 & every 2 cycles thereafter up to approximately 36 months: Predose; End of Termination Visit; 40-day Follow-up Visit (each cycle is 21 days)):
The immunogenicity of I-DXd will be assessed.

Studien-Arme

  • Experimental: Ifinatamab Deruxtecan (8 mg/kg)
    Participants will be randomized to receive I-DXd at 8 mg/kg.
  • Experimental: Ifinatamab Deruxtecan (12 mg/kg)
    Participants will be randomized to receive I-DXd at 12 mg/kg. In Part 2, all participants will receive I-DXd 12 mg/kg.

Geprüfte Regime

  • Ifinatamab Deruxtecan (I-DXd) (DS-7300a):
    I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W).

Quelle: ClinicalTrials.gov


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