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NCT02075840 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 303
- Enrollment target
NCT02075840 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 303 participants.
The verdict
NCT02075840, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 303 participants
- Enrollment target
Study Summary
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
Interventions
- DRUG Alectinib
- DRUG Crizotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2014-08-19 |
| Est. Completion | 2025-04-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02075840
The ClinicalTrials.gov registry entry for NCT02075840 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alectinib is the first listed.
NCT02075840 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02075840 about?
NCT02075840 is a clinical study titled "A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants". This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCL...
What is the current status of trial NCT02075840?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2014-08-19. Estimated completion is 2025-04-28.
What interventions are being tested in trial NCT02075840?
The interventions under investigation include: Alectinib (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT02075840?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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