A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Phase 4CompletedNCT00451906

Hoffmann-La Roche2,252 enrolled

Overview

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,252

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, \>=18 years of age; * histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type); * ECOG PS status 0-2; * life expectancy \>= 12weeks; * adequate renal, liver and hematological function. Exclusion Criteria: * mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component; * hemoptysis (\>=1/2 teaspoon of bright red blood) in previous 3 months; * evidence of tumor invading major blood vessels on imaging; * evidence of CNS metastases, even if previously treated. * major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment; * prior chemotherapy for stage IIIb/IV disease.

Locations (369)

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

Chaco-resistencia, Argentina

Unnamed facility

Córdoba, Argentina

Unnamed facility

Córdoba, Argentina

Unnamed facility

San Miguel de Tucumán, Argentina

Unnamed facility

St Leonards, New South Wales, Australia

Outcomes

Primary Outcomes

Number of Participants With Adverse Events of Special Interest

Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.

Time frame: Up to 3 years

Number of Participants With Serious Adverse Events Related to Bevacizumab

Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.

Time frame: Up to 3 years

Secondary Outcomes

Duration of Overall Survival

Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.

Time frame: Up to 3 years

Time to Disease Progression

Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Time frame: Up to 3 years

Number of Participants With Central Nervous System Bleeding

The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.

Time frame: Up to 3 years