A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.

A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773188

Enrollment

Registered

2008-10-16

Start date

2008-12-31

Completion date

2010-10-31

Last updated

2016-11-02

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

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Brief summary

This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Interventions

DRUGbevacizumab [Avastin]

7.5mg/kg iv or 15mg/kg iv every 3 weeks

DRUGcisplatin

75mg/m2 iv according to a standard chemotherapy treatment protocol

DRUGvinorelbine

15mg/m2 iv according to a standard chemotherapy treatment protocol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients \>=18 years with locoregional advanced unresectable non-squamous NSCLC; * ECOG performance status of 0 or 1; * no prior thoracic head and neck irradiation or surgical resection for current lung cancer.

Exclusion criteria

* mixed, non-small cell and small cell tumors; * mixed adeno-squamous carcinomas with a predominant squamous component; * evidence of tumor invasion or encasement of major vessels; * history of grade \>=2 hemoptysis; * presence of cavitations in lung lesions at baseline.

Design outcomes

Primary

Measure	Time frame
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.	Throughout study

Secondary

Measure	Time frame
Tumor response	Week 13 and Week 22

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026