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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: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
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 |
What the registry record for NCT03456076 still lists
NCT03456076 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (20% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT03456076's enrollment target sits among peer trials
257 45th of 130 higher than 86 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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