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NCT04765059 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT04765059: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
NCT04765059 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 98 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04765059, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
Primary Outcome
Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.
Conditions Studied
Interventions
- DRUG Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
- DRUG Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
Study Locations (20)
Other
- Research Site - Beijing
- Research Site - Beijing
- Research Site - Ganzhou
- Research Site - Guangzhou
- Research Site - Jinan
- Research Site - Shenyang
- Research Site - Tianjin
- Research Site - Zhengzhou
- Research Site - Berlin
- Research Site - Cologne
- Research Site - Cologne
- Research Site - Hanover
- Research Site - München
- Research Site - Beersheba
- Research Site - Jerusalem
- Research Site - Jerusalem
- Research Site - Kfar Saba
- Research Site - Tel Aviv
Maryland
- Research Site - Silver Spring
Massachusetts
- Research Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2021-09-12 |
| Est. Completion | 2026-06-02 |
| Phase | Phase 3 |
What the registry record for NCT04765059 still lists
NCT04765059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin is the first listed.
NCT04765059 names 20 study sites across 3 states, led by Other, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04765059 about?
NCT04765059 is a clinical study titled "A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)". The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
What is the current status of trial NCT04765059?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2021-09-12. Estimated completion is 2026-06-02.
What conditions does trial NCT04765059 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04765059?
The interventions under investigation include: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin (DRUG), Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin (DRUG).
Who is sponsoring clinical trial NCT04765059?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04765059 being conducted?
This trial has 20 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04765059's enrollment target sits among peer trials
98 246th of 454 higher than 208 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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