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About
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.
Full description
This study consists of two parts and two cohorts: Part A (Phase 1b; Safety Run-in) and Part B (Phase 2; Dose Optimization), Cohort 1 (I-DXd in maintenance) and Cohort 2 (I-DXd in induction + maintenance).
The primary objective of this study is to evaluate the safety and tolerability of I-DXd in combination with atezolizumab with or without carboplatin by assessing treatment-emergent adverse events (TEAEs) and other safety parameters which will inform optimal dose selection of I-DXd in the combination regimens (Dose Optimization Part B) of this study.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Participants must meet all of 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.
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 therapy.
For Cohort 1 Part A, 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.
For Cohort 1 Part B and Cohort 2, participant has received no prior treatment for ES-SCLC.
For Cohort 1 Part B and Cohort 2, participant has at least one measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator.
For Cohort 1 Part B and Cohort 2, participant must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy.
Has ECOG PS of ≤1 (assessed within 7 days before enrollment/randomization). 8. Has adequate organ function within 7 days before the start of study treatment as specified in the study protocol.
If the participant is a female of childbearing potential, she must have a negative serum pregnancy test during Screening (within 28 days prior to randomization). Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug.
Male participants must not freeze or donate sperm starting at enrollment/randomization, throughout the Treatment Period, and for at least 4 months following the last dose of the study drug. Preservation of sperm may be considered prior to enrollment/randomization.
Female participants must not donate, or retrieve for their own use, ova from the time of enrollment/randomization and throughout the Treatment Period and for at least 7 months following the last dose of the study drug.
Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
Exclusion Criteria
Participants who meet any of the following criteria will be disqualified from entering the study:
Primary purpose
Allocation
Interventional model
Masking
149 participants in 7 patient groups
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Central trial contact
(US) Daiichi Sankyo Contact for Clinical Trial Information; (Asia) Daiichi Sankyo Contact for Clinical Trial Information
Data sourced from clinicaltrials.gov
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