BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
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| ClinicalTrials.gov Identifier: NCT00656136 |
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Recruitment Status :
Completed
First Posted : April 10, 2008
Results First Posted : November 27, 2013
Last Update Posted : July 26, 2016
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment |
| Condition |
Carcinoma, Non-Small-Cell Lung |
| Interventions |
Drug: placebo Drug: BIBW 2992 |
| Enrollment | 585 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Two-arm, randomised (2:1 ratio), double-blind , placebo-controlled, multi-centre trial. 585 patients were randomised. All patients randomized received at least one dose of study medication. |
| Arm/Group Title | Placebo Plus Best Supportive Care (BSC) | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) |
|---|---|---|
 Arm/Group Description |
Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm. | Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0). |
| Period Title: Overall Study | ||
| Started | 195 [1] | 390 [1] |
| Completed | 0 | 0 |
| Not Completed | 195 | 390 |
| Reason Not Completed | ||
| Progressive disease | 177 | 322 |
| Other Adverse Event | 5 | 51 |
| Protocol Violation | 2 | 3 |
| Patient refused to take study medication | 7 | 10 |
| Unknown and others | 4 | 4 |
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[1]
Randomised patients.
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Baseline Characteristics
| Arm/Group Title | Placebo Plus Best Supportive Care (BSC) | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | Total | |
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Arm/Group Description |
Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm. | Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 195 | 390 | 585 | |
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Baseline Analysis Population Description |
Randomized Set (RS) included all patients randomised to receive treatment
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 195 participants | 390 participants | 585 participants | |
| 59 (10.4) | 58 (10.8) | 58 (10.6) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 195 participants | 390 participants | 585 participants | |
| Female |
117 60.0%
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231 59.2%
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348 59.5%
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| Male |
78 40.0%
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159 40.8%
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237 40.5%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Number of participants |
Number Analyzed | 195 participants | 390 participants | 585 participants |
| Caucasian | 72 | 121 | 193 | |
| Eastern Asian | 110 | 227 | 337 | |
| Other Asian | 12 | 38 | 50 | |
| Other | 1 | 4 | 5 | |
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Baseline Eastern Cooperative Oncology Group (ECOG) performance score
[1] Measure Type: Number Unit of measure: Number of participants |
Number Analyzed | 195 participants | 390 participants | 585 participants |
| ECOG score = 0 | 53 | 92 | 145 | |
| ECOG score = 1 | 127 | 268 | 395 | |
| ECOG score = 2 | 15 | 30 | 45 | |
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[1]
Measure Description: ECOG Performance Score was measured on 6 point scale where 0="Fully active", 1="Restricted in physically strenuous activity" and 2="Ambulatory and capable of all self care but unable to carry out any work activities", 3="Capable of only limited self care, confined to bed or chair 50% or more of waking hours", 4="Bedbound", and 5="Death".
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
| Name/Title: | Boehringer Ingelheim Call Center |
| Organization: | Boehringer Ingelheim |
| Phone: | 1-800-243-0127 |
| EMail: | clintriage.rdg@boehringer-ingelheim.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00656136 |
| Other Study ID Numbers: |
1200.23 2007-005983-28 ( EudraCT Number: EudraCT ) |
| First Submitted: | April 4, 2008 |
| First Posted: | April 10, 2008 |
| Results First Submitted: | August 8, 2013 |
| Results First Posted: | November 27, 2013 |
| Last Update Posted: | July 26, 2016 |