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NCT01360554 · ClinicalTrials.gov registry record · Phase 3
ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 878
- Enrollment target
NCT01360554: Completed Phase 3 study, sponsored by Pfizer.
NCT01360554 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 878 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360554, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 878 participants
- Enrollment target
Study Summary
This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.
Primary Outcome
PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal
Interventions
- DRUG Dacomitinib (PF-00299804)
- DRUG Active Comparator (erlotinib)
- DRUG Placebo erlotinib
- DRUG Placebo PF00299804
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 878 participants |
| Start Date | 2011-06-16 |
| Est. Completion | 2015-09-14 |
| Phase | Phase 3 |
What the finished NCT01360554 record still lists
NCT01360554 is an interventional study that assigns participants to a tested intervention. The registered 878 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 4 interventions - of which Dacomitinib (PF-00299804) is the first listed.
NCT01360554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360554 about?
NCT01360554 is a clinical study titled "ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer". This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary obj...
What is the current status of trial NCT01360554?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 878 participants. The study started on 2011-06-16. Estimated completion is 2015-09-14.
What interventions are being tested in trial NCT01360554?
The interventions under investigation include: Dacomitinib (PF-00299804) (DRUG), Active Comparator (erlotinib) (DRUG), Placebo erlotinib (DRUG), Placebo PF00299804 (DRUG).
Who is sponsoring clinical trial NCT01360554?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360554's enrollment target sits among peer trials
878 370th of 2000 higher than 1,630 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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