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NCT01523587 · ClinicalTrials.gov registry record · Phase 3
LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 795
- Enrollment target
NCT01523587: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01523587 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 795 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01523587, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 795 participants
- Enrollment target
Study Summary
This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
Primary Outcome
Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response
Interventions
- DRUG erlotinib
- DRUG afatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 795 participants |
| Start Date | 2012-03-05 |
| Est. Completion | 2017-12-27 |
| Phase | Phase 3 |
What the finished NCT01523587 record still lists
NCT01523587 is an interventional study that assigns participants to a tested intervention. The registered 795 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which erlotinib is the first listed.
NCT01523587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01523587 about?
NCT01523587 is a clinical study titled "LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy". This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib...
What is the current status of trial NCT01523587?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 795 participants. The study started on 2012-03-05. Estimated completion is 2017-12-27.
What interventions are being tested in trial NCT01523587?
The interventions under investigation include: erlotinib (DRUG), afatinib (DRUG).
Who is sponsoring clinical trial NCT01523587?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01523587's enrollment target sits among peer trials
795 428th of 2000 higher than 1,572 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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