A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.

Eligibility criteria

Qualifiers

None

Disqualifiers

Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures.

Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.

Has histologically or cytologically confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy.

For Cohort 1, participant has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR PR, CR, or SD per RECIST v1.1 assessed by the investigator.

Trial design

Treatments tested in this trial

  • Ifinatamab deruxtecan
  • Atezolizumab
  • Carboplatin

Treatment groups

123 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Daiichi Sankyo

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator