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: July 9, 2014
Last verified: July 2014

November 4, 2011
July 9, 2014
December 2011
May 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Progression-free survival (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease control rate including complete response, partial response and stable disease at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01466660 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Objective response rate by response evaluation criteria in solid tumours version 1.1 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Disease control rate by response evaluation criteria in solid tumours version 1.1 at 6 and 9 months [ 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 shrinkage by the maximum percentage reduction from baseline sum of target lesion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Health-related quality of life measured by EQ-5D-3L [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Neoplasms
  • Drug: Afatinib
    afatinib once daily
  • Drug: gefitinib
    Gefitinib once daily
  • Experimental: afatinib
    afatinib once daily.
    Intervention: Drug: Afatinib
  • Active Comparator: gefitinib
    gefitinib once daily
    Intervention: Drug: gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
316
December 2016
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   China,   France,   Germany,   Hong Kong,   Ireland,   Korea, Republic of,   Norway,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT01466660
1200.123, 2011-001814-33
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP