Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:January 2012
End Date:March 2016

Use our guide to learn which trials are right for you!

A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the
efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with
and without GDC-0941 in patients with previously untreated advanced or recurrent non-small
cell lung cancer (NSCLC). Patients will be randomized to receive 4 cycles of
carboplatin/paclitaxel and either GDC-0941 or placebo, with (patients with non-squamous
NSCLC) or without (patients with squamous NSCLC) bevacizumab. Anticipated time on study
treatment is until disease progression or intolerable toxicity occurs. Patients in placebo
arms with disease progression may cross over to open-label active GDC-0941.


Inclusion Criteria:

- Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or
non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)

- Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE)
block or freshly cut unstained tumor slides from archival tumor tissue or a newly
collected tumor sample

- ECOG performance status of 0 or 1

- Disease that is measurable per RECIST v1.1

- Adequate hematologic and end organ function

- Use of effective contraception

Exclusion Criteria:

- NSCLC with documented EGFR mutation associated with response to EGFR inhibitors or
documented fusion gene involving ALK gene

- 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 advanced (Stage IV) or recurrent NSCLC

- Known CNS disease except for treated brain metastases

- Type I diabetes

- Type II diabetes requiring chronic therapy with insulin

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk for treatment
complications

- Medical conditions that would contraindicate bevacizumab therapy in non-squamous
NSCLC
We found this trial at
45
sites
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
411
mi
from 43215
Athens, GA
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
236
mi
from 43215
Bristol, VA
Click here to add this to my saved trials
294
mi
from 43215
Buffalo, NY
Click here to add this to my saved trials
103
mi
from 43215
Canton, OH
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
4063
mi
from 43215
Cordoba,
Click here to add this to my saved trials
163
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
1947
mi
from 43215
Encinitas, CA
Click here to add this to my saved trials
1379
mi
from 43215
Farmington, NM
Click here to add this to my saved trials
922
mi
from 43215
Fort Myers, FL
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
668
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
283
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
2099
mi
from 43215
Oakland, CA
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
Rancho Mirage, California 90070
1982
mi
from 43215
Rancho Mirage, CA
Click here to add this to my saved trials
1938
mi
from 43215
Reno, NV
Click here to add this to my saved trials
251
mi
from 43215
Roanoke, VA
Click here to add this to my saved trials
652
mi
from 43215
Rogers, AR
Click here to add this to my saved trials
2028
mi
from 43215
Roseville, CA
Click here to add this to my saved trials
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
842
mi
from 43215
Saint Petersburg, FL
Click here to add this to my saved trials
2107
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
2091
mi
from 43215
Santa Clara, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
503
mi
from 43215
Stamford, CT
Click here to add this to my saved trials
2045
mi
from 43215
Stockton, CA
Click here to add this to my saved trials
2012
mi
from 43215
Tacoma, WA
Click here to add this to my saved trials
2091
mi
from 43215
Vallejo, CA
Click here to add this to my saved trials
2083
mi
from 43215
Walnut Creek, CA
Click here to add this to my saved trials
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials