A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

Study Overview
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Brief Summary
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This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.

Official Title
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A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: bevacizumab
* Drug: carboplatin
* Drug: paclitaxel
* Drug: placebo
* Drug: PRO95780


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willingness to sign a written informed consent Histologically or cytologically confirmed NSCLC Advanced NSCLC Measurable disease ECOG performance status of 0 or 1 Age ≥ 18 years Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men Exclusion Criteria: Squamous cell histology Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization Untreated or unstable CNS metastases Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization Uncontrolled hypertension History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization Major surgical procedure within 28 days prior to randomization Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization Persistent history of gross hemoptysis relating to the patient's NSCLC Known HIV infection Known to be positive for hepatitis C or hepatitis B surface antigen Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function Use of anticoagulation therapy Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization Pregnancy (e.g., positive HCG test) or breast feeding Known sensitivity to any of the products to be administered during the study Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bevacizumab<br>* Intravenous repeating dose<br>Drug: carboplatin<br>* Intravenous repeating dose<br>Drug: paclitaxel<br>* Intravenous repeating dose<br>Drug: PRO95780<br>* Intravenous repeating dose<br>|
| Placebo Comparator: 2<br> | Drug: bevacizumab<br>* Intravenous repeating dose<br>Drug: carboplatin<br>* Intravenous repeating dose<br>Drug: paclitaxel<br>* Intravenous repeating dose<br>Drug: placebo<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Length of study | 
| Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration |  | Length of study | 
| Progression-free survival, as determined by independent review facility |  | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response and duration of response, as determined by independent review facility |  | Length of study | 
| Overall survival |  | 24 months | 
| Progression-free survival, objective response, and duration of objective response, as determined by the investigator |  | Length of study | 
| Pharmacokinetic parameters |  | Length of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Cancer, Avastin, APM4074g