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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.
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Inclusion and exclusion criteria
A full list of inclusion/exclusion criteria are available in the protocol.
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 (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.
For Cohort 2, participant has received no prior treatment for ES-SCLC.
For 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 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).
Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol.
A female subject of childbearing potential (POCBP) is eligible to participate if the following conditions are met:
A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd/atezolizumab/carboplatin is 6/5/6 months, respectively.
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
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123 participants in 7 patient groups
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Central trial contact
(Asia) Daiichi Sankyo Contact for Clinical Trial Information; (US) Daiichi Sankyo Contact for Clinical Trial Information
Data sourced from clinicaltrials.gov
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