"Multicenter, prospective, open label study , in patients with non small cell lung cancer (NSCLC), stage IIIB / IV or recurrent, after the failure of first line chemotherapy in which it's possible a treatment that evaluates the effectiveness and the safety of oral BIBF 1120 in combination with standard docetaxel therapy, which can be administered (at the discretion of the referring physician) with tri-weekly or weekly schedule

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005016-42-IT

Enrollment

180

Registered

2015-03-19

Start date

2015-06-19

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer stage IIB/IV or recurrent

Interventions

Trade Name: docetaxel Pharmaceutical Form: Concentrate for solution for infusion Product Name: vargatef Pharmaceutical Form: Capsule INN or Proposed INN: vargatef CAS Number: 656247-17-5 Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): Overall Survival OS;Timepoint(s) of evaluation of this end point: 24 months	—

Countries

Italy

Contacts

Public ContactFrancesca Arizio

Dipartimento di Oncologia-Università degli studi di Torino

francesca.arizio@unito.it+390119026978

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026