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 study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01493843
First received: December 14, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This multicenter, randomized, double-blind, placebo-controlled trial will evalua te the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/ bevacizumab with and without GDC-0941 in patients with previously untreated adva nced or recurrent non-small cell lung cancer (NSCLC). Patients will be randomize d 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 progressio n may cross over to open-label active GDC-0941.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: GDC-0941
Drug: Placebo
Drug: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Progression-free survival (PFS), defined as the time from randomization to disease progression as assessed by the investigator per RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • Duration of objective response, defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • Overall survival (OS), defined as the time from randomization until death from any cause [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
GDC-0941 + carboplatin + paclitaxel
Drug: GDC-0941
Repeating oral dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Active Comparator: B
Placebo + carboplatin + paclitaxel
Drug: Placebo
Repeating oral dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Experimental: C/E
GDC-0941 + carboplatin + paclitaxel + bevacizumab
Drug: GDC-0941
Repeating oral dose
Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Active Comparator: D/F
Placebo + carboplatin + paclitaxel + bevacizumab
Drug: Placebo
Repeating oral dose
Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493843

Contacts
Contact: Reference Study ID Number: GO27912 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35205
United States, Arkansas
Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Recruiting
Encinitas, California, United States, 92024
Recruiting
Hayward, California, United States, 94545
Recruiting
Oakland, California, United States, 94611
Recruiting
Rancho Mirage, California, United States, 92270
Recruiting
Roseville, California, United States, 95661
Recruiting
Sacramento, California, United States, 95825
Recruiting
San Diego, California, United States, 92120
Completed
San Francisco, California, United States, 94115
Recruiting
San Jose, California, United States, 95119
Recruiting
Santa Clara, California, United States, 95051
Recruiting
South San Francisco, California, United States, 94080
Terminated
Stockton, California, United States, 95204
Recruiting
Vallejo, California, United States, 94589
Recruiting
Walnut Creek, California, United States, 94596
United States, Connecticut
Recruiting
Stamford, Connecticut, United States, 06902
United States, Florida
Terminated
Boca Raton, Florida, United States, 33486
Recruiting
Fort Myers, Florida, United States, 33905
Recruiting
Jacksonville, Florida, United States, 32256
Terminated
Miami, Florida, United States, 33176
Recruiting
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Recruiting
Athens, Georgia, United States, 30607
Recruiting
Atlanta, Georgia, United States, 30318
Recruiting
Atlanta, Georgia, United States, 30341
United States, Indiana
Terminated
Indianapolis, Indiana, United States, 46260
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
Recruiting
Boston, Massachusetts, United States, 02114
Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, Nebraska
Recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Terminated
Reno, Nevada, United States, 89502
United States, New Mexico
Recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Recruiting
Buffalo, New York, United States, 14263
United States, North Carolina
Recruiting
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Terminated
Canton, Ohio, United States, 44718
Recruiting
Cincinnati, Ohio, United States, 45219
Recruiting
Cleveland, Ohio, United States, 44106
United States, Tennessee
Recruiting
Bristol, Tennessee, United States, 37620
Recruiting
Knoxville, Tennessee, United States, 37909
Terminated
Nashville, Tennessee, United States, 37232
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Recruiting
Seattle, Washington, United States, 98108
Recruiting
Tacoma, Washington, United States, 98405
Argentina
Recruiting
Cordoba, Argentina, X5004FHP
Recruiting
La Plata, Argentina, B1900BAJ
Active, not recruiting
Santa Fe, Argentina, 03000
Australia, New South Wales
Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Active, not recruiting
Darlinghurst, New South Wales, Australia, 2010
Active, not recruiting
Newcastle, New South Wales, Australia, 2298
Australia, South Australia
Active, not recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Active, not recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Active, not recruiting
Footscray, Victoria, Australia, 3011
Terminated
Parkville, Victoria, Australia, 3052
Brazil
Recruiting
Salvador, BA, Brazil, 41820-021
Recruiting
Brasilia, DF, Brazil, 70390-055
Recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Recruiting
Natal, RN, Brazil, 59040150
Recruiting
Porto Alegre, RS, Brazil, 90020-090
Recruiting
Porto Alegre, RS, Brazil, 90110-270
Recruiting
Florianopolis, SC, Brazil, 88034-000
Terminated
Jau, SP, Brazil, 17210-080
Recruiting
Sao Paulo, SP, Brazil, 01246-000
Recruiting
Sorocaba, SP, Brazil, 18030-245
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H3A 1A1
Recruiting
Montreal, Quebec, Canada, J4B 5Z7
Chile
Recruiting
Santiago, Chile, 0
Recruiting
Santiago, Chile, Providencia
Recruiting
Temuco, Chile, 4810469
Recruiting
Viña del Mar, Chile, 2520612
France
Recruiting
Brest, France, 29200
Recruiting
Le Mans, France, 72015
Terminated
Nantes, France, 44202
Recruiting
Saint Herblain, France, 44805
Completed
Villefranche-sur-Saone, France, 69655
Active, not recruiting
Villejuif, France, 94805
Germany
Completed
Bad Berka, Germany, 99437
Recruiting
Gauting, Germany, 82131
Recruiting
Grosshansdorf, Germany, 22927
Recruiting
Karlsruhe, Germany, 76137
Recruiting
Mainz, Germany, 55131
Recruiting
Regensburg, Germany, 93053
Recruiting
Ulm, Germany, 89081
Recruiting
Villingen-Schwenningen, Germany, 78052
Hungary
Recruiting
Budapest, Hungary, 1529
Recruiting
Edeleny, Hungary, 3780
Terminated
Farkasgyepu, Hungary, 8582
Active, not recruiting
Szombathely, Hungary, 9700
Recruiting
Torokbalint, Hungary, 2045
Terminated
Zalaegerszeg, Hungary, 8900
Israel
Recruiting
Jerusalem, Israel, 9372212
Recruiting
Kfar-Saba, Israel, 4428164
Recruiting
Ramat Gan, Israel, 52620-00
Italy
Recruiting
Bologna, Emilia-Romagna, Italy, 40139
Recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
Recruiting
Monza, Lombardia, Italy, 20052
Active, not recruiting
Orbassano, Piemonte, Italy, 10043
Terminated
Verona, Veneto, Italy, 37134
Netherlands
Recruiting
Breda, Netherlands, 4818 CK
Terminated
Eindhoven, Netherlands, 5623 EJ
Recruiting
Groningen, Netherlands, 9713 GZ
Russian Federation
Recruiting
Chelyabinsk, Russian Federation, 454087
Recruiting
Moscow, Russian Federation, 143423
Recruiting
Nizhny Novgorod, Russian Federation, 603000
Active, not recruiting
St Petersburg, Russian Federation, 194291
Recruiting
St. Petersburg, Russian Federation, 189646
Spain
Terminated
Avila, Spain, 05071
Active, not recruiting
Barcelona, Spain, 08035
Active, not recruiting
Barcelona, Spain, 08916
Recruiting
Madrid, Spain, 28041
Active, not recruiting
Madrid, Spain, 28222
Ukraine
Terminated
Kiev, Ukraine, 03115
Terminated
Lutsk, Ukraine, 43018
Recruiting
Lviv, Ukraine, 79031
Completed
Simferopol, Ukraine, 95023
Recruiting
Sumy, Ukraine, 40005
Recruiting
Zaporizhzhya, Ukraine, 69040
United Kingdom
Recruiting
Guildford, United Kingdom, GU2 7XX
Recruiting
Leicester, United Kingdom, LE1 5WW
Recruiting
Manchester, United Kingdom, M2O 4BX
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01493843     History of Changes
Other Study ID Numbers: GO27912
Study First Received: December 14, 2011
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014