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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

Open Label Study of Avastin in Combination With Platinum-containing Chemotherapy as 1st Line Treatment in Patients With Stage IIIb/IV Non-squamous NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451906
• Other study ID #: MO19390
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2007
• Last updated: December 1, 2015
• Start date: October 2006
• Est. completion date: June 2009

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2118
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Platinum-based chemotherapy
As prescribed
• bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Bosnia and Herzegovina,  Brazil,  Canada,  China,  Colombia,  Czech Republic,  Denmark,  Ecuador,  Egypt,  Estonia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Iceland,  Israel,  Italy,  Latvia,  Lebanon,  Lithuania,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters.		Throughout study	No
Secondary	Duration of survival; time to disease progression.		Event driven	No