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Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
NCT05687266 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Durvalumab
- DRUG Datopotamab deruxtecan
Study Locations (20)
Florida
- Research Site — Fort Myers
- Research Site — Jacksonville
- Research Site — St. Petersburg
- Research Site — West Palm Beach
Arkansas
- Research Site — Hot Springs
- Research Site — Little Rock
- Research Site — Springdale
California
- Research Site — Fountain Valley
- Research Site — Los Angeles
- Research Site — Orange
Iowa
- Research Site — Bettendorf
- Research Site — Iowa City
- Research Site — Waukee
Arizona
- Research Site — Phoenix
- Research Site — Tucson
Louisiana
- Research Site — Baton Rouge
- Research Site — Covington
Colorado
- Research Site — Boulder
Illinois
- Research Site — Hinsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,350 participants |
| Start Date | 2022-12-29 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05687266
The ClinicalTrials.gov registry entry for NCT05687266 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with NSCLC appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05687266 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05687266 about?
NCT05687266 is a clinical study titled "Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations". This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line t...
What is the current status of trial NCT05687266?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,350 participants. The study started on 2022-12-29. Estimated completion is 2027-11-01.
What conditions does trial NCT05687266 study?
This clinical trial studies the following conditions: NSCLC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05687266?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Durvalumab (DRUG), Datopotamab deruxtecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05687266?
This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05687266 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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