Status:
COMPLETED
LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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;
- Eastern Cooperative Oncology group (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 neoadjuvant 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-cancer therapy 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
Exclusion
Key Trial Info
Start Date :
December 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2017
Estimated Enrollment :
1314 Patients enrolled
Trial Details
Trial ID
NCT00805194
Start Date
December 3 2008
End Date
November 13 2017
Last Update
December 5 2018
Active Locations (210)
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1
LKH-Univ. Hospital Graz
Graz, Austria, 8036
2
KH St. Vinzenz, Zams, Int. Abtlg.
Kufstein, Austria, 6330
3
AKH d. Stadt Linz, Pulmologie
Linz, Austria, 4020
4
Bobruisk Inter-distict
Babruysk, Belarus, 213825