Clinical trial NCT00532155: A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Official title: A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated With Second-Line Docetaxel After Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma
Non Small Cell Lung
Keywords: lung cancer
angiogenesis inhibitor
chemotherapy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2007-09-20
Enrollment: 913
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study included:

* A screening visit of up to 21 days prior to randomization
* Randomization at baseline (Treatment was initiated with 3 days of randomization)
* A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment
* A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline to the date when 687 deaths occurred (26 January 2011)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline to data cut-off (26 January 2011)
measure: Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
timeFrame: Baseline to data cut-off (26 January 2011)
measure: Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)
timeFrame: Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.
measure: Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)
timeFrame: Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Macquarie Park
country: Australia
facility: sanofi-aventis Australia & New Zealand administrative office
state: New South Wales
city: Wien
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Shangai
country: China
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Athens
country: Greece
facility: Sanofi-Aventis Administrative Office
city: Causeway Bay
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Kuala Lumpur
country: Malaysia
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administraive Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Admnistrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N, Scagliotti G. Aflibercept and Docetaxel versus Docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol. 2012 Oct 10;30(29):3640-7. doi: 10.1200/JCO.2012.42.6932. Epub 2012 Sep 10.