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)
Daiichi Sankyo
Summary
This study was 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).
Description
The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 extensive-stage small cell lung cancer (ES-SCLC). 4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content. 5. Has received prior…
Interventions
- DrugIfinatamab deruxtecan
12 mg/kg intravenous dose on Day 1 of each 21-day cycle
- DrugTopotecan
Topotecan will be administered per local SoC.
- DrugAmrubicin
Amrubicin will be administered per local SoC.
- DrugLurbinectedin
Lurbinectedin will be administered per local SoC
Locations (230)
- Highlands Oncology GroupSpringdale, Arkansas
- Clinical Research Providence Medical FoundationFullerton, California
- UCLA Hematology-OncologyLos Angeles, California
- UCSF Mission Bay Mission HallSan Francisco, California
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer CenterMiami, Florida
- AdventHealth Orlando, Cancer InstituteOrlando, Florida