Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Ifinatamab Deruxtecan (I-DXd): I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W).
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.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC — Up to approximately 36 months
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.
Trial sites (58)
| Facility | City | Region | Status |
|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | |
| The Cancer Specialists, Llc | Jacksonville | Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| University of Chicago Medical Center | Chicago | Illinois | |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | |
| Dana-Faeber Cancer Institute | Boston | Massachusetts | |
| Henry Ford Hospital | Detroit | Michigan | |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | |
| Washington University School of Medicine | St Louis | Missouri | |
| Hackensack Meridian Health-Southern Ocean Medical Center | Manahawkin | New Jersey | |
| Memorial Sloan-Kettering Cancer Center (Mskcc) - New York | New York | New York | |
| Montefiore Medical Center Prime | The Bronx | New York | |
| Duke University Health System | Durham | North Carolina | |
| Sarah Cannon (Tennessee Oncology - Nashville) | Nashville | Tennessee | |
| Millennium Physicians Association, Llp | Houston | Texas | |
| University of Washington Medical Center | Seattle | Washington | |
| Jilin Cancer Hospital | Changchun | China | |
| Hunan Cancer Hospital | Changsha | China | |
| West China Hospital, Sichuan University | Chengdu | China | |
| Guangdong Provincial People'S Hospital | Guangdong | China | |
| Zhejiang Cancer Hospital | Hangzhou | China | |
| Linyi Cancer Hospital | Linyi | China | |
| Fudan University Shanghai Cancer Center | Shanghai | China | |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | China | |
| Centre Hospitalier Intercommunal de Créteil | Créteil | France | |
| Centre Leon Berard | Lyon | France | |
| Hôpital Nord - Chu Marseille | Marseille | France | |
| CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | France | |
| Hopital Arnaud de Villeneuve | Montpellier | France | |
| Institut Curie - Site de Paris | Paris | France | |
| Hopital Tenon | Paris | France | |
| Evangelische Lungenklinik Berlin | Berlin | Germany | |
| Universitaetsklinikum Essen | Essen | Germany | |
| National Cancer Center Hospital | Chūōku | Japan | |
| National Cancer Center Hospital East | Kashiwa | Japan | |
| The Cancer Institute Hospital of Jfcr | Kōtoku | Japan | |
| Shizuoka Cancer Center | Nagaizumi-chō | Japan | |
| Osaka International Cancer Institute | Osaka | Japan | |
| Kindai University Hospital | Ōsaka-sayama | Japan | |
| Kanagawa Cancer Center | Yokohama | Japan |
+ 18 more sites — see the full list on the official registry below.
More Daiichi Sankyo trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05280470 on ClinicalTrials.gov ↗ ← All trials in the USA