Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Datopotamab deruxtecan: Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle
Durvalumab: Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle
Carboplatin: Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle
AZD2936: Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle
MEDI5752: Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle
AZD7789: Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle
Study summary
This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Eligibility
Primary outcome measure(s)
- Number of participants with DLTs; TEAEs and other safety parameters during the study. — DLTs: within first cycle (21 days); TEAEs and other safety parameters: when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up (approximately 60 months)
DLTs, TEAEs, SAEs, AESIs, ECOG PS, vital sign measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | La Jolla | California | |
| Research Site | Santa Ana | California | |
| Research Site | St Louis | Missouri | |
| Research Site | Hackensack | New Jersey | |
| Research Site | Cleveland | Ohio | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Dallas | Texas | |
| Research Site | Houston | Texas | |
| Research Site | San Antonio | Texas | |
| Research Site | Fairfax | Virginia | |
| Research Site | Hasselt | Belgium | |
| Research Site | Roeselare | Belgium | |
| Research Site | Aviano | Italy | |
| Research Site | Meldola | Italy | |
| Research Site | Orbassano | Italy | |
| Research Site | Roma | Italy | |
| Research Site | Kōtoku | Japan | |
| Research Site | Sunto-gun | Japan | |
| Research Site | Yokohama | Japan | |
| Research Site | Gdansk | Poland | |
| Research Site | Lodz | Poland | |
| Research Site | Lublin | Poland | |
| Research Site | Warsaw | Poland | |
| Research Site | A Coruña | Spain | |
| Research Site | Badalona | Spain | |
| Research Site | Barcelona | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Seville | Spain | |
| Research Site | Hsinchu | Taiwan | |
| Research Site | Taichung | Taiwan | |
| Research Site | Tainan | Taiwan | |
| Research Site | Taipei | Taiwan | |
| Research Site | Taipei | Taiwan | |
| Research Site | Taipei | Taiwan | |
| Research Site | Taoyuan | Taiwan | |
| Research Site | Adana | Turkey (Türkiye) | |
| Research Site | Ankara | Turkey (Türkiye) | |
| Research Site | Ankara | Turkey (Türkiye) |
+ 2 more sites — see the full list on the official registry below.
On this site
📄 Imfinzi (durvalumab) drug profile →More AstraZeneca trials in Italy
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 NCT04612751 on ClinicalTrials.gov ↗ ← All trials in Italy