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



Status:Completed
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:March 5, 2012
End Date:December 27, 2017

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LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line 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 as second-line treatment in this group of patients.


Inclusion criteria:

1. Diagnosis of advanced stage NSCLC squamous histology.

2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC.

3. Eligible to receive 2nd line therapy in the opinion of the investigator.

4. Measurable disease according to RECIST 1.1.

5. Adequate Performance Status.

6. Availability of tumour tissue material for correlative studies. Archived tumour tissue
is acceptable.

7. Adequate organ function.

8. Age = 18 years and above.

9. Written informed consent that is consistent with International Conference on
Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.

Exclusion criteria:

1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules
or antibodies.

2. Radiotherapy within 4 weeks prior to randomization.

3. Active brain metastases .

4. Any other current malignancy or malignancy diagnosed within the past three (3) years
(other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ
prostate cancer).

5. Known pre-existing interstitial lung disease.

6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major
symptom

7. Any other concomitant serious illness or organ system dysfunction which in the opinion
of the investigator would either compromise patient safety or interfere with the
evaluation of the safety of the test drug.

8. Women of child-bearing potential and men who are able to father a child, unwilling to
be abstinent or use adequate contraception prior to study entry, for the duration of
study participation and for at least 2 months after treatment has ended.

9. Female patients of childbearing potential (see Section 4.2.3.3) who:

1. are nursing or

2. are pregnant or

3. are not using an acceptable method of birth control, or do not plan to continue
using this method throughout the study and/or do not agree to submit to pregnancy
testing required by this protocol.

10. Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C
infection (defined as presence of Hep C RNA) and/or known HIV carrier.

11. Known or suspected active drug or alcohol abuse in the opinion of the investigator.

12. Any contraindications for therapy with afatinib or erlotinib.

13. Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial
drugs.

14. Major surgery within 4 weeks of starting study treatment.

15. Prior participation in an afatinib clinical study, even if not assigned to afatinib.

16. Use of any investigational drug within 4 weeks of randomisation (unless a longer time
period is required by local regulations or by the guidelines for the investigational
product).

17. Patients without Progression of their lung cancer.
We found this trial at
33
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Billings, Montana 59101
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701 Northwest 13th Street
Boca Raton, Florida 33486
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Burlington, MA
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Chandler, Arizona 85224
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Christiansburg, Virginia 24073
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Ciudad Autonoma de Bs As,
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Cookeville, TN
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Detroit, Michigan 48201
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100 Hospital Avenue
DuBois, Pennsylvania 15801
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Fresh Meadows, New York 11365
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Hollywood, Florida
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La Jolla, California 92093
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Lake City, Florida 32024
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Lawrence, Massachusetts 01841
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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Niles, Illinois 60714
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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3550 Northeast Loop 286
Paris, Texas 75460
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925 Chestnut Street
Philadelphia, Pennsylvania 19107
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3401 North Broad Street
Philadelphia, Pennsylvania 19140
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Portland, Oregon 97227
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Sacramento, California 95816
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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7979 Wurzbach Road
San Antonio, Texas 78229
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Skokie, Illinois 60076
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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750 East Adams Street
Syracuse, New York 13210
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