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NCT03456076 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 257
- Enrollment target
- 20
- Study locations
NCT03456076 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 257 participants, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT03456076, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 257 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
- DRUG Vinorelbine
- DRUG Alectnib
Study Locations (20)
Other
- Krankenhaus Nord - Klinik Floridsdorf - Vienna
- Clinical center University of Sarajevo - Sarajevo
- Beijing Cancer Hospital - Beijing
- Jilin Cancer Hospital - Changchun
- West China Hospital, Sichuan University - Chengdu
- Fujian Medical University Union Hospital - Fujian
- Guangdong General Hospital - Guangzhou
- Zhejiang Cancer Hospital - Hangzhou
- Shandong Cancer Hospital - Jinan
- Shanghai Chest Hospital - Shanghai
- Zhongshan Hospital Fudan University - Shanghai
New South Wales
- Chris O'Brien Lifehouse - Camperdown
- GenesisCare North Shore - St Leonards
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- MGH Cancer Center - Boston
Pennsylvania
- AHN Cancer Institute ? Allegheny General Hospital - Pittsburgh
Victoria
- Peter MacCallum Cancer Center - Melbourne
Grodnenskaya
- Healthcare Institution Grodno University Hospital - Hrodna
Homyel'skaya Voblasts'
- Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary? - Homyel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2018-08-16 |
| Est. Completion | 2026-11-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03456076
The ClinicalTrials.gov registry entry for NCT03456076 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 257 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (20% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT03456076 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, New South Wales, Illinois.
Frequently Asked Questions
What is clinical trial NCT03456076 about?
NCT03456076 is a clinical study titled "A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer". This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with...
What is the current status of trial NCT03456076?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 257 participants. The study started on 2018-08-16. Estimated completion is 2026-11-19.
What conditions does trial NCT03456076 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03456076?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG), Vinorelbine (DRUG), Alectnib (DRUG).
Who is sponsoring clinical trial NCT03456076?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03456076 being conducted?
This trial has 20 study locations across Illinois, Massachusetts, Pennsylvania, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.