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NCT05280470 · ClinicalTrials.gov registry record · Phase 2
Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
A Phase 2 study of Extensive-stage Small-cell Lung Cancer, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT05280470: Active Phase 2 study of Extensive-stage Small-cell Lung Cancer, sponsored by Daiichi Sankyo.
NCT05280470 is a Phase 2 study of Extensive-stage Small-cell Lung Cancer that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 187 participants, above the 168-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05280470, a Phase 2 study of Extensive-stage Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Daiichi Sankyo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.
Primary Outcome
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR based on RECIST version 1.1. For all target, non-target, and new lesions, CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of all lesions.
Conditions Studied
Interventions
- DRUG Ifinatamab Deruxtecan (I-DXd)
Study Locations (20)
Other
- Jilin Cancer Hospital - Changchun
- Hunan Cancer Hospital - Changsha
- West China Hospital, Sichuan University - Chengdu
- Guangdong Provincial People'S Hospital - Guangdong
Florida
- The Cancer Specialists, Llc - Jacksonville
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Michigan
- Henry Ford Hospital - Detroit
- Cancer and Hematology Centers of Western Michigan - Grand Rapids
New York
- Memorial Sloan-Kettering Cancer Center (Mskcc) - New York - New York
- Montefiore Medical Center Prime - The Bronx
Arkansas
- Highlands Oncology Group - Springdale
Illinois
- University of Chicago Medical Center - Chicago
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
Massachusetts
- Dana-Faeber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2022-03-09 |
| Est. Completion | 2026-12-15 |
| Phase | Phase 2 |
What the registry record for NCT05280470 still lists
NCT05280470 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Extensive-stage Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Ifinatamab Deruxtecan (I-DXd) is the first listed.
NCT05280470 names 20 study sites across 14 states, led by Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05280470 about?
NCT05280470 is a clinical study titled "Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)". This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemo...
What is the current status of trial NCT05280470?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2022-03-09. Estimated completion is 2026-12-15.
What conditions does trial NCT05280470 study?
This clinical trial studies the following conditions: Extensive-stage Small-cell Lung Cancer.
What interventions are being tested in trial NCT05280470?
The interventions under investigation include: Ifinatamab Deruxtecan (I-DXd) (DRUG).
Who is sponsoring clinical trial NCT05280470?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05280470 being conducted?
This trial has 20 study locations across Arkansas, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05280470's enrollment target sits among peer trials
187 9th of 25 higher than 17 of 25 other Extensive-stage Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Extensive-stage Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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