Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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
Secondary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Progression-Free Survival (PFS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Duration of Response (DoR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Eligibility Criteria
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. * Eas…
Read full criteria on CT.gov →✦ Analyst Commentary
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