Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ch...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of advanced stage NSCLC squamous histology.
- Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC.
- Eligible to receive 2nd line therapy in the opinion of the investigator.
- Measurable disease according to RECIST 1.1.
- Adequate Performance Status.
- Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable.
- Adequate organ function.
- Age = 18 years and above.
- Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.
- Exclusion criteria:
- Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies.
- Radiotherapy within 4 weeks prior to randomization.
- Active brain metastases .
- 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).
- Known pre-existing interstitial lung disease.
- Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom
- 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.
- 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.
- Female patients of childbearing potential (see Section 4.2.3.3) who:
- are nursing or
- are pregnant or
- 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.
- 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.
- Known or suspected active drug or alcohol abuse in the opinion of the investigator.
- Any contraindications for therapy with afatinib or erlotinib.
- Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs.
- Major surgery within 4 weeks of starting study treatment.
- Prior participation in an afatinib clinical study, even if not assigned to afatinib.
- 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).
- Patients without Progression of their lung cancer.
Exclusion
Key Trial Info
Start Date :
March 5 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2017
Estimated Enrollment :
795 Patients enrolled
Trial Details
Trial ID
NCT01523587
Start Date
March 5 2012
End Date
December 27 2017
Last Update
February 15 2019
Active Locations (192)
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1
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
2
University of California
La Jolla, California, United States, 92093
3
Sutter Medical Group
Sacramento, California, United States, 95816
4
Boca Raton Reginl Hospital-Lynn Cancer Institute
Boca Raton, Florida, United States, 33486