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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01493843
First received: December 14, 2011
Last updated: March 19, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Squamous 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 ]

Enrollment: 494
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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35211
United States, Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Encinitas, California, United States, 92024
Hayward, California, United States, 94545
Oakland, California, United States, 94611
Rancho Mirage, California, United States, 92270
Roseville, California, United States, 95661
Sacramento, California, United States, 95825
San Diego, California, United States, 92120
San Francisco, California, United States, 94115
San Jose, California, United States, 95119
Santa Clara, California, United States, 95051
South San Francisco, California, United States, 94080
Stockton, California, United States, 95204
Vallejo, California, United States, 94589
Walnut Creek, California, United States, 94596
United States, Connecticut
Stamford, Connecticut, United States, 06902
United States, Florida
Boca Raton, Florida, United States, 33486
Fort Myers, Florida, United States, 33905
Jacksonville, Florida, United States, 32256
Miami, Florida, United States, 33176
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Athens, Georgia, United States, 30607
Atlanta, Georgia, United States, 30318
Atlanta, Georgia, United States, 30341
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Maryland
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Reno, Nevada, United States, 89502
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, New York
Buffalo, New York, United States, 14263
United States, North Carolina
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Canton, Ohio, United States, 44718
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44106
United States, Tennessee
Bristol, Tennessee, United States, 37620
Knoxville, Tennessee, United States, 37909
Nashville, Tennessee, United States, 37232
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle, Washington, United States, 98108
Tacoma, Washington, United States, 98405
Argentina
Cordoba, Argentina, X5004FHP
La Plata, Argentina, B1900BAJ
Santa Fe, Argentina, 03000
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Darlinghurst, New South Wales, Australia, 2010
Newcastle, New South Wales, Australia, 2298
Australia, South Australia
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Footscray, Victoria, Australia, 3011
Parkville, Victoria, Australia, 3052
Brazil
Salvador, BA, Brazil, 41820-021
Brasilia, DF, Brazil, 70390-055
Rio de Janeiro, RJ, Brazil, 20560-120
Natal, RN, Brazil, 59040150
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 90110-270
Florianopolis, SC, Brazil, 88034-000
Jau, SP, Brazil, 17210-080
Sao Paulo, SP, Brazil, 01246-000
Sorocaba, SP, Brazil, 18030-245
Canada, Quebec
Montreal, Quebec, Canada, J4B 5Z7
Montreal, Quebec, Canada, H3A 1A1
Chile
Santiago, Chile, Providencia
Santiago, Chile, 0
Temuco, Chile, 4810469
Viña del Mar, Chile, 2520612
France
Brest, France, 29200
Le Mans, France, 72015
Nantes, France, 44202
Saint Herblain, France, 44805
Villefranche-sur-Saone, France, 69655
Villejuif, France, 94805
Germany
Bad Berka, Germany, 99437
Gauting, Germany, 82131
Grosshansdorf, Germany, 22927
Karlsruhe, Germany, 76137
Mainz, Germany, 55131
Regensburg, Germany, 93053
Ulm, Germany, 89081
Villingen-Schwenningen, Germany, 78052
Hungary
Budapest, Hungary, 1529
Edeleny, Hungary, 3780
Farkasgyepu, Hungary, 8582
Szombathely, Hungary, 9700
Torokbalint, Hungary, 2045
Zalaegerszeg, Hungary, 8900
Israel
Jerusalem, Israel, 9372212
Kfar-Saba, Israel, 4428164
Ramat Gan, Israel, 52620-00
Italy
Bologna, Emilia-Romagna, Italy, 40139
Aviano, Friuli-Venezia Giulia, Italy, 33081
Monza, Lombardia, Italy, 20052
Orbassano, Piemonte, Italy, 10043
Verona, Veneto, Italy, 37134
Netherlands
Breda, Netherlands, 4818 CK
Eindhoven, Netherlands, 5623 EJ
Groningen, Netherlands, 9700 RB
Russian Federation
Chelyabinsk, Russian Federation, 454087
Moscow, Russian Federation, 143423
Nizhny Novgorod, Russian Federation, 603000
St Petersburg, Russian Federation, 194291
St. Petersburg, Russian Federation, 189646
Spain
Avila, Spain, 05071
Barcelona, Spain, 08035
Barcelona, Spain, 08916
Madrid, Spain, 28041
Madrid, Spain, 28222
Ukraine
Kiev, Ukraine, 03115
Lutsk, Ukraine, 43018
Lviv, Ukraine, 79031
Simferopol, Ukraine, 95023
Sumy, Ukraine, 40005
Zaporizhzhya, Ukraine, 69040
United Kingdom
Guildford, United Kingdom, GU2 7XX
Leicester, United Kingdom, LE1 5WW
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: March 19, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 30, 2015