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NCT03421353 · ClinicalTrials.gov registry record · Phase 1
AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT03421353: Completed Phase 1 study, sponsored by AstraZeneca.
NCT03421353 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03421353, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is a phase Ib/II, open-label multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 plus durvalumab alone or in combination with chemotherapy in patients with advanced, solid tumours and subsequently in patients with non-small-cell lung cancer (NSCLC)
Primary Outcome
The Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) will be determined by assessment of the incidence of dose-limiting toxicities (DLTs). DLTs may come from the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), the change from baseline in vital signs, clinical chemistry, haemotology, and urinalysis parameters will be evaluated for each treatment arm in Part A of the study.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Durvalumab
- DRUG AZD9150
- DRUG 5-Flourouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2018-02-07 |
| Est. Completion | 2024-03-28 |
| Phase | Phase 1 |
What the finished NCT03421353 record still lists
NCT03421353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03421353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03421353 about?
NCT03421353 is a clinical study titled "AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer". This is a phase Ib/II, open-label multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 plus durvalumab alone or in combination with chemotherapy in patients with advanced, solid tumours and subsequently in patients with non-small-cell...
What is the current status of trial NCT03421353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2018-02-07. Estimated completion is 2024-03-28.
What interventions are being tested in trial NCT03421353?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Durvalumab (DRUG), AZD9150 (DRUG), 5-Flourouracil (DRUG).
Who is sponsoring clinical trial NCT03421353?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03421353's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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