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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease


Inclusion Criteria:



- Histologically or cytologically documented inoperable (Stage IV) or recurrent
non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC
that are based on sputum cytology alone are not acceptable. Mixed tumors should be
categorized according to the predominant cell type.

- ECOG performance status of 0 or 1

- Life expectancy >12 weeks

- Measurable disease, as defined by RECIST 1.1

- Adequate hematologic and end organ function

Exclusion Criteria:

- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase
inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy)
before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients
who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded
if the time interval from completion of adjuvant therapy until disease progression is
> 12 months.

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment

- Malignancies other than NSCLC within 5 years prior to randomization, except for
adequately treated carcinoma in situ of the cervix, basal or squamous cell skin
cancer, localized prostate cancer treated surgically with curative intent, ductal
carcinoma in situ treated surgically with curative intent

- Pregnant and lactating women

- Active infection requiring IV antibiotics

Bevacizumab-Specific Exclusions:

- Histologically or cytologically documented inoperable, locally advanced, mixed
non-small cell and small cell tumors or mixed adenosquamous carcinomas with a
predominant squamous component

- Evidence of tumor invading major blood vessels on imaging

- Evidence of central nervous system (CNS) metastases

- History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1

- Significant vascular disease within 6 months prior to Day 1

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Ina Rhee, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MEF4984g

NCT ID:

NCT01366131

Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

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

Name

Location

Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Eugene, Oregon  
Indianapolis, Indiana  
Las Vegas, Nevada  89109