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NCT01090011 · ClinicalTrials.gov registry record · Phase 1
Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
NCT01090011: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT01090011 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 171 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01090011, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
Study Summary
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib or gefitinib. Overall safety, pharmacokinetics and anti-tumor activity for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib, gefitinib or BIBW 2992 will be evaluated as secondary objectives. Initially a standard, 3+3 dose escalation will be performed to determine the MTD of BIBW 2992 when administered together with cetuximab in patients with advanced non small cell lung cancer and acquired resistance to erlotinib or gefitinib. Subsequently, the preliminary efficacy and safety of the identified MTD of cetuximab administered with BIBW 2992 will be explored in a combo arm via a further expansion of MTD cohort up to a total of 140 EGFR mutation positive NSCLC with acquired resistance to erlotinib/gefitinib. Furthermore, the safety and preliminary anti-tumor activity of the combination therapy in EGFR mutant NSCLC patients who developed acquired resistance (AR) to BIBW 2992, will be assessed in a sequential arm. The sequential arm will use a two-stage design with an early stopping rule after 12 patients with acquired resistance to BIBW 2992 have received up to 5 courses of BIBW 2992 plus cetuximab. If no responses are seen in 12 patients during 5 courses of combination therapy, accrual in the sequential arm will stop. If 1 or more responses are observed, the sequential arm will expand up to about 40 patients.
Primary Outcome
A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria: * CTCAE Grade 2 or higher decrease in cardiac left ventricular function * CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy * CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days * CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard an
Interventions
- DRUG Cetuximab
- DRUG BIBW 2992
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01090011 record still lists
NCT01090011 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT01090011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01090011 about?
NCT01090011 is a clinical study titled "Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer". The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib or gefitinib. Overall safety, pharmacokinetics and anti...
What is the current status of trial NCT01090011?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2010-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01090011?
The interventions under investigation include: Cetuximab (DRUG), BIBW 2992 (DRUG).
Who is sponsoring clinical trial NCT01090011?
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 NCT01090011's enrollment target sits among peer trials
171 324th of 2000 higher than 1,676 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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