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NCT02013219 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 17
- Study locations
NCT02013219: Completed Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche.
NCT02013219 is a Phase 1 study of Non-Small Cell Lung Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 52 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (92% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013219, a Phase 1 study of Non-Small Cell Lung Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 17
- Study locations
Study Summary
This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in participants with NSCLC. This study has two stages. In the erlotinib group, the combination treatment will be given to participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages (Stages 1 and 2), the combination will be given to participants who are treatment-naive with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO) once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28 consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated, alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that combination treatment. In Stage 2, a potential RP2D and schedule for each combination treatment will be investigated in an expansion cohort. For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the treating investigator. Study treatment will be discontinued in participants who experience disease progression or unacceptable toxicity, are not compliant with the study protocol, or, in their opinion or in the opinion of the investigator, are not benefiting from study treatment. However, in the absence of unacceptable t
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Alectinib
- DRUG Erlotinib
Study Locations (17)
Other
- Institut Gustave Roussy - Villejuif
- The Chinese University of Hong Kong - Shatin
- Seoul National University Hospital - Seoul
- Asan Medical Center - Seoul
- START Madrid. Centro Integral Oncologico Clara Campal; CIOCC - Madrid
- Hospital Clinico Universitario de Valencia - Valencia
- Queen Mary University of London - London
Massachusetts
- Massachusetts General Hospital;Hematology/ Oncology - Boston
- Beth Israel Deaconess Med Ctr; Neurology/MS Center - Boston
- Dana Farber Cancer Institute - Boston
California
- UC Irvine Medical Center - Orange
Connecticut
- Yale University School Of Medicine - New Haven
Florida
- Florida Hospital Cancer Inst - Orlando
Illinois
- University of Chicago - Chicago
Michigan
- Karmanos Cancer Center; Department of Oncology - Detroit
New York
- Memorial Sloan Kettering - Basking Ridge - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-04-03 |
| Est. Completion | 2020-02-05 |
| Phase | Phase 1 |
What the finished NCT02013219 record still lists
NCT02013219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 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 (92% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT02013219 lists 17 locations in 9 states (Other, Massachusetts, California).
Frequently Asked Questions
What is clinical trial NCT02013219 about?
NCT02013219 is a clinical study titled "A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)". This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in participants with NSCLC. This study has two stages. In the erlotinib group, the combination treatment will be g...
What is the current status of trial NCT02013219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2014-04-03. Estimated completion is 2020-02-05.
What conditions does trial NCT02013219 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02013219?
The interventions under investigation include: Atezolizumab (DRUG), Alectinib (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT02013219?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02013219 being conducted?
This trial has 17 study locations across California, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02013219's enrollment target sits among peer trials
52 330th of 454 higher than 122 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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