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NCT01221077 · ClinicalTrials.gov registry record · Phase 2
Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
A Phase 2 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT01221077: Completed Phase 2 study, sponsored by Astellas Pharma.
NCT01221077 is a Phase 2 study that has completed, run by Astellas Pharma. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01221077, a Phase 2 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study Summary
A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.
Primary Outcome
Time from randomization to disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator or death due to any cause, whichever occurs first.
Interventions
- DRUG Placebo
- DRUG Erlotinib
- DRUG OSI-906
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2011-04-08 |
| Est. Completion | 2014-09-01 |
| Phase | Phase 2 |
What the finished NCT01221077 record still lists
NCT01221077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01221077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01221077 about?
NCT01221077 is a clinical study titled "Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene". A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.
What is the current status of trial NCT01221077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2011-04-08. Estimated completion is 2014-09-01.
What interventions are being tested in trial NCT01221077?
The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), OSI-906 (DRUG).
Who is sponsoring clinical trial NCT01221077?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01221077's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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