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LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01466660
First received: November 4, 2011
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.


Condition Intervention Phase
Lung Neoplasms
Drug: Afatinib
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to Treatment Failure (TTF) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to objective response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Duration of disease control [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tumour shirinkage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Health-related quality of life (HRQoL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 316
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: afatinib
afatinib once daily.
Drug: Afatinib
afatinib once daily
Active Comparator: gefitinib
gefitinib once daily
Drug: gefitinib
Gefitinib once daily

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
  2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
  3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  5. Age >= 18 years.
  6. Adequate organ function as defined by the following criteria:

Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =< 3 x upper limit of normal (ULN), or AST and ALT =<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =<1.5 x ULN Absolute neutrophil count (ANC) >=1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L

Exclusion criteria:

  1. Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
  2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
  3. Major surgery within 4 weeks of study randomisation.
  4. Active brain metastases
  5. Meningeal carcinomatosis.
  6. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
  7. Known pre-existing interstitial lung disease.
  8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
  9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
  10. Women of child-bearing potential (WOCBP) 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.
  11. Pregnancy or breast-feeding.
  12. Active hepatitis and/or known HIV carrier
  13. Any prohibited concomitant medications for therapy with afatinib or gefitinib
  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: NCT01466660

  Show 64 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: NCT01466660     History of Changes
Other Study ID Numbers: 1200.123, 2011-001814-33
Study First Received: November 4, 2011
Last Updated: November 5, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Hong Kong: Department of Health
Ireland: Irish Medicines Board
Norway: Norwegian Medicines Agency
Singapore: Health Sciences Authority
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014