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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06203210




Registration number
NCT06203210
Ethics application status
Date submitted
2/01/2024
Date registered
12/01/2024

Titles & IDs
Public title
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Scientific title
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
Secondary ID [1] 0 0
2023-509628-16
Secondary ID [2] 0 0
DS7300-188
Universal Trial Number (UTN)
Trial acronym
IDeate-Lung02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ifinatamab deruxtecan
Treatment: Drugs - Topotecan
Treatment: Drugs - Amrubicin
Treatment: Drugs - Lurbinectedin

Experimental: Ifinatamab deruxtecan (I-DXd) - Participants randomized to receive 12 mg/kg I-DXd monotherapy on Day 1 of each 21-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.

Active comparator: Treatment of Physician's Choice (TPC) - Participants randomized to receive topotecan, lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.


Treatment: Drugs: Ifinatamab deruxtecan
12 mg/kg intravenous dose on Day 1 of each 21-day cycle

Treatment: Drugs: Topotecan
Topotecan will be administered per local SoC.

Treatment: Drugs: Amrubicin
Amrubicin will be administered per local SoC.

Treatment: Drugs: Lurbinectedin
Lurbinectedin will be administered per local SoC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review
Timepoint [1] 0 0
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Primary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
From the date of randomization to the date of death due to any cause, whichever occurs first, up to approximately 4.5 years
Secondary outcome [1] 0 0
Number of Participants With Objective Response Rate Assessed by Investigator
Timepoint [1] 0 0
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Secondary outcome [2] 0 0
Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator
Timepoint [2] 0 0
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Secondary outcome [3] 0 0
Duration of Response As Assessed by Blinded Independent Central Review and Investigator
Timepoint [3] 0 0
From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 4.5 years
Secondary outcome [4] 0 0
Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator
Timepoint [4] 0 0
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Secondary outcome [5] 0 0
Time to Response As Assessed by Blinded Independent Central Review and Investigator
Timepoint [5] 0 0
From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 4.5 years
Secondary outcome [6] 0 0
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Timepoint [6] 0 0
Baseline up to 4.5 years
Secondary outcome [7] 0 0
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)
Timepoint [7] 0 0
Baseline up to 4.5 years
Secondary outcome [8] 0 0
Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd Monotherapy
Timepoint [8] 0 0
Baseline up to 4.5 years
Secondary outcome [9] 0 0
The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody
Timepoint [9] 0 0
Baseline up to 4.5 years
Secondary outcome [10] 0 0
Pharmacokinetic Parameter Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Timepoint [10] 0 0
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
Secondary outcome [11] 0 0
Pharmacokinetic Parameter Time to Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Timepoint [11] 0 0
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
Secondary outcome [12] 0 0
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Timepoint [12] 0 0
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)

Eligibility
Key inclusion criteria
Inclusion Criteria

Participants must meet all the following criteria to be eligible for randomization into the study:

1. Sign and date the informed consent form 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 informed consent form is signed.
3. Has histologically or cytologically documented SCLC.
4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy-free interval of >30 days.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
7. Has documentation of radiological disease progression on or after the most recent systemic therapy.
8. Has ECOG PS of =1.
9. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases that are no longer symptomatic (ie, without neurologic signs or symptoms) and who require no treatment with steroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Subjects must have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 humanized anti-B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.
4. Has inadequate washout period before randomization as specified in the protocol.
5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
6. Has uncontrolled or significant cardiovascular disease.
7. Has clinically significant corneal disease.
8. Has 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.
9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/02/2029
Actual
Sample size
Target
468
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [2] 0 0
Flinders Medical Centre (Fmc) - Bedford Park
Recruitment hospital [3] 0 0
Chris Oâbrien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [5] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [6] 0 0
Townsville Cancer Centre - Townsville
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment postcode(s) [6] 0 0
4814 - Townsville
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Feldkirch
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Krems
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Linz
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United Kingdom
State/province [180] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Director
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
9089926400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06203210