A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Daiichi Sankyo
Study ID
NCT06203210
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ifinatamab deruxtecan — DRUG
    12 mg/kg intravenous dose on Day 1 of each 21-day cycle
  • Topotecan — DRUG
    Topotecan will be administered per local standard-of-care (SoC)
  • Amrubicin — DRUG
    Amrubicin will be administered per local SoC
  • Lurbinectedin — DRUG
    Lurbinectedin will be administered per local SoC

Study Details

This study is designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

Key Dates

First listed
Jan 12, 2024
Start date
May 21, 2024
Status verified
Aug 2026
Primary completion
Jan 30, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ifinatamab deruxtecan (I-DXd)
    Participants will be randomized to receive 12 milligrams per kilogram (mg/kg) I-DXd, intravenously (IV), as monotherapy on Day 1 of each 21-day cycle, once every 3 weeks (Q3W), until clinical or radiologic evidence of progression of disease determined by the investigator, unacceptable toxicity, withdrawal of informed consent, death, loss to follow-up, or other treatment discontinuation criteria are met as specified in the protocol.
  • Active Comparator: Treatment of Physician's Choice (TPC)
    Participants will be randomized to receive topotecan or lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criteria are met as specified in the protocol.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause, up to approximately 3.7 years ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupSpringdaleArkansas72762
Principal Investigator
Clinical Research Providence Medical FoundationFullertonCalifornia92835
Principal Investigator
UCLA Hematology-OncologyLos AngelesCalifornia90095
Principal Investigator
UCSF Mission Bay Mission HallSan FranciscoCalifornia94115
Principal Investigator
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Principal Investigator
AdventHealth Orlando, Cancer InstituteOrlandoFlorida32804
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute, IncTampaFlorida33612
Principal Investigator
Rush MD Anderson Cancer CenterChicagoIllinois60612
Principal Investigator
Baptist Health LexingtonLexingtonKentucky40503
Principal Investigator
John Hopkins School of MedicineBaltimoreMaryland21287
Principal Investigator
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Principal Investigator
Dana-Farber Cancer InstituteBostonMassachusetts02216
Principal Investigator
Henry Ford Health SystemDetroitMichigan48202
Principal Investigator
Mercy Clinic Oncology and Hematology Sindelar Cancer CenterSt LouisMissouri63128
Principal Investigator
University of Nebraska Medical CenterOmahaNebraska68198-6811
Principal Investigator
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03766
Principal Investigator
Astera Cancer CareEast BrunswickNew Jersey08816
Principal Investigator
Hackensack Meridian Health JsumcNeptune CityNew Jersey07753
Principal Investigator
Clinical Research Alliance, IncLake SuccessNew York11042
Principal Investigator
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long IslandNew YorkNew York10016
Principal Investigator
New York University Cancer Center - Laura and IsaacNew YorkNew York10016-
Montefiore Medical Center PrimeThe BronxNew York10461
Principal Investigator
Cleveland Clinic Mercy HospitalCantonOhio44708
Principal Investigator
Oncology/Hematology Care Clinical Trials, LlcCincinnatiOhio45236
Principal Investigator
Providence Portland Medical CenterPortlandOregon97213
Principal Investigator
THE WEST CLINIC, PLLC dba West Cancer CenterGermantownTennessee38138
Principal Investigator
Houston Methodist Cancer CenterHoustonTexas77030
Principal Investigator
University of Texas Md Anderson Cancer CenterHoustonTexas77030
Principal Investigator
Texas Oncology, P.A. - TylerTylerTexas75702
Principal Investigator
Medical College of WisconsinMilwaukeeWisconsin53226
Principal Investigator

Find similar trials in Springdale, AR

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Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group· Springdale, ARClinical Research Providence Medical Foundation· Fullerton, CAUCLA Hematology-Oncology· Los Angeles, CAUCSF Mission Bay Mission Hall· San Francisco, CAUniversity of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center· Miami, FLAdventHealth Orlando, Cancer Institute· Orlando, FL

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