Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Aaron Lisberg, MD (ucla)
Headshot of Aaron Lisberg
Aaron Lisberg

Description

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).

Official 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)

Details

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.

Keywords

Small Cell Lung Cancer, Ifinatamab deruxtecan, I-DXd, Lung Neoplasms, Small Cell Lung Carcinoma, Topotecan, Amrubicin, Lurbinectedin, Ifinatamab deruxtecan (I-DXd)

Eligibility

Locations

  • UCLA Hematology-Oncology accepting new patients
    Los Angeles California 90095 United States
  • Ucsf Mount Zion Medical Ctr not yet accepting patients
    San Francisco California 94115 United States
  • Clinical Research Providence Medical Foundation accepting new patients
    Fullerton California 92835 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo
ID
NCT06203210
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 540 study participants
Last Updated