Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

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

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

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.

Locations

  • UCSF Mount Zion Medical Ctr not yet accepting patients
    San Francisco California 94115 United States
  • David Geffen School of Medicine not yet accepting patients
    Los Angeles California 90095 United States
  • Clinical Research Alliance, Inc accepting new patients
    Lake Success New York 11042 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo
ID
NCT06203210
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 468 study participants
Last Updated