ME-Lung 1: BIBF 1120 plus docetaxel as compared to placebo plus docetaxel in 2nd line non small cell lung cancer

Phase 1

• Conditions: stage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapy; MedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-004803-36-DE
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-11
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1300

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 (according to American Joint Committee on Cancers) or recurrent
NSCLC (all histologies)
• relapse or failure of one first line prior chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy)
• at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT
• life expectancy of at least three months
• ECOG score of 0 or 1
• patient has given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

• more than one prior chemotherapy regimen for advanced and/or metastatic disease or recurrent NSCLC
• more than one chemotherapy treatment regimen prior to first line chemotherapy of advanced and/or metastatic or recurrent NSCLC
• 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 treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
• chemo-, hormone-, radio-(except for extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past four weeks prior to treatment with the trial drug. I.e. the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
• radiotherapy (except extremities and brain) within the past three months prior to baseline imaging
• active brain metastases
• 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 and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with
acetylsalicylic acid = 325mg per day)
• history of major thrombotic or clinically relevant major bleeding event in the past 6 months
• known inherited predisposition to bleeding or thrombosis
• significant cardiovascular disease
• inadequate safety laboratory parameters
• significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial
• current peripheral neuropathy = 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 (e.g antiviral, antimicrobial, antifungal) 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 such as neurologic-, psychiatric-, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
• patients unwilling to use a medically acceptable contraception
• pregnancy or breast feeding
• psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol
• 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 hypersensitivity to docetaxel, polysorbate 80 (Tween 80), BIBF 1120, contrast media

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): progression free survival;Timepoint(s) of evaluation of this end point: At baseline, every 6 weeks thereafter starting with the very first docetaxel administration, at the end of treatment visit and at the end of study visit (last patient visit according to the clinical trial protocol). For further information, please kindly refer to the clinical trial protocol precedures flowchart.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • overall survival (key secondary endpoint)<br>• tumour response according to the modified RECIST criteria (objective tumour response, disease control, duration of disease control)<br>• incidence and intensity of adverse events according to the common terminology criteria for adverse events (CTCAE version 3.0)<br>• clinical improvement<br>• changes in safety laboratory parameters<br>• quality of life measured by standardized questionnaires (EQ-5D, EORTC QLQ-C-30, EORTC QLQ-LC-13)<br>• pharmacokinetics of BIBF 1120 (and of clinical relevant metabolites, if feasible);Timepoint(s) of evaluation of this end point: Please kindly refer to the clinical trial protocol precedures flowchart and to section 6.2 (Trial procedures at each visit) of the clincial trial protocol.