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 study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01523587
First received: January 30, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: afatinib
Drug: erlotinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression-free survival, as determined by RECIST 1.1 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 795
Study Start Date: March 2012
Estimated Study Completion Date: November 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib
Patients receive afatinib tablets once daily
Drug: afatinib
Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
Active Comparator: Erlotinib
Patients receive erlotinib tablets once daily
Drug: erlotinib
erlotinib taken once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ICH-GCP guidelines.

Exclusion criteria:

  1. Prior treatment with 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523587

  Show 192 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01523587     History of Changes
Other Study ID Numbers: 1200.125, 2011-002380-24
Study First Received: January 30, 2012
Last Updated: August 6, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Denmark: The Danish Health and Medicines Authority
France: Agence Nationale sécurité médicament et des produits santé
Germany: Paul-Ehrlich-Institute
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Italy: Ethics Committee
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014