Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362252
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-01-02
Brief Title:
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
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1b2 Multicenter Open-label Study of Ifinatamab Deruxtecan I-DXd a B7-H3 Antibody-Drug Conjugate ADC in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance in Subjects With Extensive-stage Small Cell Lung Cancer ES-SCLC IDeate-Lung03
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509629-36 | OTHER | EU CT | None |