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NCT04612751 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 1 study of Advanced or Metastatic NSCLC, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
- 20
- Study locations
NCT04612751: Active Phase 1 study of Advanced or Metastatic NSCLC, sponsored by AstraZeneca.
NCT04612751 is a Phase 1 study of Advanced or Metastatic NSCLC that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 155 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04612751, a Phase 1 study of Advanced or Metastatic NSCLC, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Durvalumab
- DRUG Datopotamab deruxtecan
- DRUG AZD2936
- DRUG MEDI5752
Study Locations (20)
Other
- Research Site - Hasselt
- Research Site - Roeselare
- Research Site - Aviano
- Research Site - Meldola
- Research Site - Orbassano
- Research Site - Roma
- Research Site - Kōtoku
- Research Site - Sunto-gun
- Research Site - Yokohama
- Research Site - Gdansk
Texas
- Research Site - Dallas
- Research Site - Houston
- Research Site - San Antonio
California
- Research Site - La Jolla
- Research Site - Santa Ana
Missouri
- Research Site - St Louis
New Jersey
- Research Site - Hackensack
Ohio
- Research Site - Cleveland
Pennsylvania
- Research Site - Philadelphia
Virginia
- Research Site - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2021-02-02 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
What the registry record for NCT04612751 still lists
NCT04612751 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher).
The record links to 1 condition, with Advanced or Metastatic NSCLC appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04612751 names 20 study sites across 8 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT04612751 about?
NCT04612751 is a clinical study titled "Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer". 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).
What is the current status of trial NCT04612751?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2021-02-02. Estimated completion is 2026-04-30.
What conditions does trial NCT04612751 study?
This clinical trial studies the following conditions: Advanced or Metastatic NSCLC.
What interventions are being tested in trial NCT04612751?
The interventions under investigation include: Carboplatin (DRUG), Durvalumab (DRUG), Datopotamab deruxtecan (DRUG), AZD2936 (DRUG), MEDI5752 (DRUG).
Who is sponsoring clinical trial NCT04612751?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04612751 being conducted?
This trial has 20 study locations across California, Missouri, New Jersey, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced or Metastatic NSCLC
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 NCT04612751's enrollment target sits among peer trials
155 352nd of 2000 higher than 1,645 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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