Multicenter, prospective, open label study , in patients with non small celllung cancer (NSCLC), stage IIIB / IV or recurrent, after the failure of firstline chemotherapy in which it's possible a treatment that evaluates theeffectiveness and the safety of oral BIBF 1120 in combination withstandard docetaxel therapy, which can be administered (at the discretionof the referring physician) with tri-weekly or weekly schedule
- Conditions
- on Small Cell Lung Cancer stage IIB/IV or recurrentTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-005016-42-IT
- Lead Sponsor
- Dipartimento di Oncologia-Università degli studi di Torino
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 180
patients> 18 years; ECOG PS 0-1; disease stage IIIB / IV according to
the classification RECIST 1.1 with a cytotoxic or histo-logical diagnosis
of NSCLC (non-squamous) and who have previously received only
chemotherapy (except for treatment neo-adjuvant or adjuvant, from
which must be spent at least 12 months compared to study entry); the
presence of at least one measurable lesion according to RECIST (version
1.1).
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
are excluded patients with a previous diagnosis of oncologic pathology ,
except for non-melanoma skin cancers, carcinoma in situ of the cervix or
other forms of cancer from which the patient must, however, be free
from at least 3 years prior to study enrollment; patients with known
positivity for molecular studies such as EGFR and ALK; previous
treatment with TKIs or inhibitors of ALK; presence of brain metastases
unstable (defined as stable if spent four weeks from a previous radiation
therapy); previous chemotherapy with docetaxel or VEGFR inhibitors
(except for Avastin, which is allowed by the study); more than one line
of chemotherapy treatment (with the exception above to neoadjuvant or
adjuvant treatment); persistent and non-hematological toxicities in
reference to previous treatments carried out; presence of cavitations in
the lung or evidence on CT or MRI of tumors central or local invasion of
the major vessels, or a recent history (<3 months) of hemoptysis or
bleeding or thrombotic event more important in the previous six months;
anticoagulant therapy (except heparin bpm) or antiplatelet therapy
(except aspirin dosage <325mg daily); significant cardiac disease
(unstable angina, myo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression Free Survival PFS;Secondary Objective: Overall Survival OS;Primary end point(s): Progression Free Survival PFS;Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall Survival OS;Timepoint(s) of evaluation of this end point: 24 months