A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Official Title
-----------------
An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: Cisplatin
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, ≥ 18 years of age. Stage IIIb or IV non-small cell lung cancer. Chemotherapy-naive. Exclusion Criteria: Previous treatment for non-small cell lung cancer. Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study. Recent or current chronic treatment with aspirin (> 325 mg/day).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab + cisplatin + docetaxel<br>Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. | Drug: Bevacizumab<br>* Bevacizumab was supplied as a sterile liquid in glass vials.<br>* Other names: Avastin;Drug: Cisplatin<br>* Bevacizumab was supplied as a sterile liquid in glass vials.<br>Drug: Docetaxel<br>* Bevacizumab was supplied as a sterile liquid in glass vials.<br>* Other names: Taxotere;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. | Baseline to the end of the study (up to 4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Objective Response | An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. | Baseline to the end of the study (up to 4 years) | 
| Duration of the Objective Response | Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. | Baseline to the end of the study (up to 4 years) | 
| Overall Survival | Overall survival is defined as the time from the first dose of study medication until death. | Baseline to the end of the study (up to 4 years) | 
| 1-year Survival | The probability of surviving 1 year was estimated using the Kaplan-Meier method. | Baseline to 1 year |