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A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

NCT00532155

CompletedPhase 3

Sponsor: Sanofi

Conditions: Carcinoma, Non Small Cell Lung

Interventions: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), Placebo, Docetaxel (Taxotere®), Dexamethasone (pre- and post-medication for docetaxel)

Countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile

The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Histological/cytological proven locally advanced or metastatic non-small cell lung cancer
* Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Adequate renal, liver and bone marrow functions

Exclusion Criteria:

* Squamous histology/cytology
* Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
* Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \> 25% of bone marrow
* Prior docetaxel treatment
* Uncontrolled hypertension

The above information was not intended to contain all considerations relevant to participation in a clinical trial.

Locations (32)

Bridgewater, New Jersey, United States
Buenos Aires, Argentina
Macquarie Park, New South Wales, Australia
Vienna, Austria
São Paulo, Brazil
Sofia, Bulgaria
Laval, Canada
Santiago, Chile
Shanghai, China
Prague, Czechia
Tallinn, Estonia
Helsinki, Finland
Paris, France
Berlin, Germany
Athens, Greece
Causeway Bay, Hong Kong
Budapest, Hungary
Mumbai, India
Milan, Italy
Kuala Lumpur, Malaysia
Gouda, Netherlands
Warsaw, Poland
Porto Salvo, Portugal
Bucharest, Romania
Moscow, Russia
Singapore, Singapore
Seoul, South Korea
Barcelona, Spain
Bromma, Sweden
Taipei, Taiwan
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