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A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
NCT01801111 · View on ClinicalTrials.gov ↗
Study Summary
This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.
Conditions Studied
Interventions
- DRUG Alectinib
- DRUG Erlotinib
Study Locations (20)
California
- St. Jude Heritage Healthcare — Fullerton
- UC Irvine Medical Center — Orange
- Sharp Memorial Hospital — San Diego
- Coastal Integrative Cancer Care — San Luis Obispo
- UCLA Cancer Center; Premiere Oncology, A Medical Corporation — Santa Monica
Florida
- Advanced Medical Specialties — Miami
- Florida Hospital Cancer Inst — Orlando
Illinois
- Rush University Medical Center — Chicago
- Midwestern Regional Medical Center; Office of Research — Zion
Texas
- Texas Oncology, P.A. — Dallas
- Cancer Care Centers of South Texas — San Antonio
Queensland
- Prince Charles Hospital — Chermside
- Townsville General Hospital — Douglas
Alabama
- University of Alabama at Birmingham — Birmingham
Missouri
- Washington University; Wash Uni. Sch. Of Med — St Louis
Nevada
- Comprehensive Cancer Centers of Nevada — Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2013-06-20 |
| Est. Completion | 2017-10-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01801111
The ClinicalTrials.gov registry entry for NCT01801111 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Alectinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01801111 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01801111 about?
NCT01801111 is a clinical study titled "A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment". This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally...
What is the current status of trial NCT01801111?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2013-06-20. Estimated completion is 2017-10-27.
What conditions does trial NCT01801111 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01801111?
The interventions under investigation include: Alectinib (DRUG), Erlotinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01801111?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01801111 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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