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Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
NCT04686305 · View on ClinicalTrials.gov ↗
Study Summary
DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- BIOLOGICAL Durvalumab
- DRUG T-DXd
Study Locations (20)
Other
- Research Site — Adelaide
- Research Site — Heidelberg
- Research Site — Nedlands
- Research Site — Edegem
- Research Site — Barretos
- Research Site — Porto Alegre
- Research Site — São Paulo
California
- Research Site — Duarte
- Research Site — Newport Beach
- Research Site — Orange
- Research Site — Santa Rosa
New York
- Research Site — Buffalo
- Research Site — New York
- Research Site — The Bronx
Kansas
- Research Site — Westwood
Maryland
- Research Site — Baltimore
Michigan
- Research Site — Detroit
Texas
- Research Site — Houston
Virginia
- Research Site — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04686305
The ClinicalTrials.gov registry entry for NCT04686305 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 244 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 Locally Advanced or Metastatic Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin 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: NCT04686305 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, New York. 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 NCT04686305 about?
NCT04686305 is a clinical study titled "Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC". DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.
What is the current status of trial NCT04686305?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2021-03-09. Estimated completion is 2027-06-30.
What conditions does trial NCT04686305 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04686305?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Durvalumab (BIOLOGICAL), T-DXd (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04686305?
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 NCT04686305 being conducted?
This trial has 20 study locations across California, Kansas, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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