LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
progression free survival [ Time Frame: 6 months ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00805194 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 8, 2008)
overall survival, tumour response, quality of life, safety, pharmacokinetics [ Time Frame: 12 months ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJELUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
Official Title  ICMJELUME Lung 1 Randomised Double Blind Phase III Trial of BIBF 1120 Versus Placebo in Addition to Standard Therapy of Docetaxel in Patients With Advanced NSCLC
Brief Summary

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Efficacy Study
Condition  ICMJECarcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: BIBF 1120
  • Drug: placebo
  • Drug: docetaxel

Recruitment Information

Estimated Enrollment  ICMJE1300
Completion Date 
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female patient aged 18 years or older;
  • histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;
  • relapse or failure of one first line prior chemotherapy;
  • at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured ;
  • life expectancy of at least three months;
  • ECOG score of 0 or 1;
  • patient has given written informed consent

Exclusion Criteria:

  • more than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC;
  • more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjvant plus adjuvant) prior to first line chemotherapy;
  • previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC;
  • persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
  • treatment with other investigational drugs or other anti-cancertherapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial ;
  • radiotherapy (except extremities and brain) within the past three months prior to baseline imaging;
  • active brain metastases or leptomeningeal disease;
  • radiographic evidence of cavitary or necrotic tumours;
  • centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels;
  • history of clinically significant haemoptysis within the past 3 months;
  • therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy;
  • history of major thrombotic or clinically relevant major bleeding event in the past 6 months;
  • known inherited predisposition to bleeding or thrombosis;
  • significant cardiovascular diseases ;
  • inadequate safety laboratory parameters;
  • significant weight loss (> 10 %) within the past 6 weeks;
  • current peripheral neuropathy greater than CTCAE grade 2 except due to trauma;
  • preexisting ascites and/or clinically significant pleural effusion;
  • major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing;
  • serious infections requiring systemic antibiotic therapy;
  • decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy;
  • gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug;
  • active or chronic hepatitis C and/or B infection;
  • serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration;
  • patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for at least twelve months after end of active therapy;
  • pregnancy or breast feeding;
  • psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;
  • patients unable to comply with the protocol;
  • active alcohol or drug abuse;
  • other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix;
  • any contraindications for therapy with docetaxel;
  • history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80);
  • hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;
  • hypersensitivity to contrast media
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study
Location Countries  ICMJEAustria,   Belarus,   Belgium,   Bulgaria,   Croatia,   Czech Republic,   Denmark,   France,   Georgia,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Switzerland,   Ukraine,   United Kingdom

Administrative Information

Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1199.13, Eudra CT No: 2007-004803-36
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals