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

An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404703

Enrollment

Registered

2006-11-29

Start date

2006-08-31

Completion date

2008-02-29

Last updated

2016-08-24

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

Conditions

Non-Small Cell Lung Cancer

Brief summary

This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Interventions

DRUGbevacizumab [Avastin]

15mg iv on day 1 of each 3 week cycle

DRUGPlatinum-based chemotherapy

As prescribed

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

* adult patients, \>=18 years of age; * documented squamous non-small cell lung cancer; * stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease; * suitable for platinum-based treatment as first line chemotherapy.

Exclusion criteria

* prior systemic anti-tumor therapy; * prior radiotherapy for treatment of patient's current stage of disease; * other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix; * major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.

Design outcomes

Primary

Measure	Time frame
Rate of grade >=3 Avastin-related pulmonary hemorrhage	After a maximum of 12 months treatment

Secondary

Measure	Time frame
Overall response, duration of response, progression-free survival.	Event driven
AEs, laboratory parameters, coagulation parameters.	Throughout study

Countries

Australia, Belgium, Czechia, France, Hungary, Israel, Poland, Russia, Spain, Taiwan

Outcome results

None listed

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