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Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01493843
First received: December 14, 2011
Last updated: April 21, 2017
Last verified: April 2017
  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 pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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) [ Time Frame: Up to approximately 2.5 years ]
  • PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification [ Time Frame: Up to approximately 2.5 years ]
  • PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low [ Time Frame: Up to approximately 2.5 years ]

Secondary Outcome Measures:
  • Objective Tumor Response [ Time Frame: Up to approximately 2.5 years ]
  • Objective Tumor Response in Participants with PIK3CA Amplification [ Time Frame: Up to approximately 2.5 years ]
  • Objective Tumor Response in Participants with PTEN Loss/low [ Time Frame: Up to approximately 2.5 years ]
  • Duration of Objective Response (DoR) [ Time Frame: Up to approximately 2.5 years ]
  • DoR in Participants with PIK3CA Amplification [ Time Frame: Up to approximately 2.5 years ]
  • DoR in Participants with PTEN Loss/low [ Time Frame: Up to approximately 2.5 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 2.5 years ]
  • OS in Participants with PIK3CA Amplification [ Time Frame: Up to approximately 2.5 years ]
  • OS in Participants with PTEN Loss/low [ Time Frame: Up to approximately 2.5 years ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 4 years ]

Enrollment: 501
Actual Study Start Date: January 20, 2012
Study Completion Date: March 30, 2016
Primary Completion Date: March 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: 340 mg pictilisib + CP
Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P).
Drug: pictilisib
Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.
Other Name: GDC-0941
Drug: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Drug: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Placebo Comparator: Arm B: Placebo + CP
Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm A during the first 4 cycles with carboplatin + paclitaxel or after chemotherapy has been completed (Cycle >/= 5).
Drug: Placebo
Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
Drug: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Drug: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Experimental: Arm C: 340 mg pictilisib + CPB
Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).
Drug: pictilisib
Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.
Other Name: GDC-0941
Drug: bevacizumab
Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
Other Name: Avastin
Drug: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Drug: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Placebo Comparator: Arm D: Placebo + CPB
Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm C during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle >/= 5).
Drug: Placebo
Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
Drug: bevacizumab
Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
Other Name: Avastin
Drug: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Drug: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Experimental: Arm E: 260 mg pictilisib + CPB
Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).
Drug: pictilisib
Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.
Other Name: GDC-0941
Drug: bevacizumab
Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
Other Name: Avastin
Drug: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Drug: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
Placebo Comparator: Arm F: Placebo + CPB
Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm E during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle >/= 5).
Drug: Placebo
Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
Drug: bevacizumab
Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
Other Name: Avastin
Drug: carboplatin
Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
Drug: paclitaxel
Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Adequate hematologic and end organ function
  • Use of two effective forms of contraception

Exclusion Criteria:

  • NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma kinase (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 central nervous system (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 participant at high risk for treatment complications
  • Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F)
  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
Alabama Oncology
Birmingham, Alabama, United States, 35211
United States, Arkansas
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
United States, California
cCare
Encinitas, California, United States, 92024
Kaiser Permanente - Oakland
Oakland, California, United States, 94611
Desert Hematology Oncology Group
Rancho Mirage, California, United States, 92270
Kaiser Permanente - Roseville
Roseville, California, United States, 95661
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States, 95825
Southern CA Permanente Med Grp
San Diego, California, United States, 92120
Kaiser Permanente
San Francisco, California, United States, 94115
K. Permanente - Santa Clara
Santa Clara, California, United States, 95051
Stockton Hema Onc Med Grp Inc
Stockton, California, United States, 95204
Kaiser Permanente - Vallejo
Vallejo, California, United States, 94589
K. Permanente - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Connecticut
Hematology Oncology PC; Bennett Cancer Center
Stamford, Connecticut, United States, 06902
United States, Florida
Lynn Regional Cancer Center West
Boca Raton, Florida, United States, 33486
Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
Fort Myers, Florida, United States, 33905
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States, 32256
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
Saint Petersburg, Florida, United States, 33705
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Peachtree Hematology & Oncology Consultants, Pc
Atlanta, Georgia, United States, 30318
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
United States, Indiana
Hematology-Oncology of Indiana, Pc
Indianapolis, Indiana, United States, 46260
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University; Hemat/Onc, 4HW CRC
Detroit, Michigan, United States, 48201
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Va Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
Roswell Park Cancer Inst.
Buffalo, New York, United States, 14263
United States, North Carolina
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Univ Hosp Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Tennessee
Center for Biomedical Research LLC
Knoxville, Tennessee, United States, 37909
The Sarah Cannon Research Inst
Nashville, Tennessee, United States, 37203
Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Wellmonth Physician Services
Bristol, Virginia, United States, 24201
Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, United States, 24014
United States, Washington
VA Puget Sound Health Care Sys
Seattle, Washington, United States, 98108
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Argentina
Clinica Universitaria Reina Fabiola
Cordoba, Argentina, X5004FHP
Instituto FIDES
La Plata, Argentina, B1900BAJ
Isis Centro Especializado de Luces; Oncology
Santa Fe, Argentina, 03000
Australia, New South Wales
Royal Prince Alfred Hospital; Sydney Cancer Centre
Camperdown, New South Wales, Australia, 2050
St Vincent'S Hospital
Darlinghurst, New South Wales, Australia, 2010
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, South Australia
Flinders Medical Centre; Medical Oncology
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital; Medical Oncology
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Footscray Hospital
Footscray, Victoria, Australia, 3011
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia, 3052
Brazil
Centro de Oncologia da Bahia - CENOB
Salvador, BA, Brazil, 41820-021
Clinica de Tratamento e Pesquisa Oncologica - Oncotek
Brasilia, DF, Brazil, 70390-055
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, RJ, Brazil, 20560-120
Liga Norte Riograndense Contra O Câncer
Natal, RN, Brazil, 59040150
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90020-090
Hospital Mae de Deus
Porto Alegre, RS, Brazil, 90110-270
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC, Brazil, 88034-000
Hospital Amaral Carvalho
Jau, SP, Brazil, 17210-080
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, SP, Brazil, 18030-245
Canada, Quebec
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada, H3A 1A1
Hopital du Sacre-Coeur
Montreal, Quebec, Canada, J4B 5Z7
Chile
Clinica Santa Maria
Santiago, Chile, 0
Fundacion Arturo Lopez Perez
Santiago, Chile, 7500921
Instituto Oncologico del sur
Temuco, Chile, 4810469
Hospital Clinico Vina del Mar
Viña del Mar, Chile, 2520612
France
Hopital Morvan
Brest, France, 29200
Clinique Victor Hugo; Radiotherapie
Le Mans, France, 72015
Clinique Catherine de Sienne; Service de cancérologie
Nantes, France, 44202
Ico Rene Gauducheau; Oncologie
Saint Herblain, France, 44805
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saone, France, 69655
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, France, 94805
Germany
Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie
Bad Berka, Germany, 99437
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting, Germany, 82131
Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie
Grosshansdorf, Germany, 22927
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe, Germany, 76137
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, Germany, 55131
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg, Germany, 93053
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, Germany, 89081
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, Germany, 78052
Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, Hungary, 1121
Koch Robert Korhaz
Edeleny, Hungary, 3780
Veszprem Megyei Onkormanyzat Tudogyogyintezet
Farkasgyepu, Hungary, 8582
Vas Megyei Markusovszky Korhaz ; Pulmonology
Szombathely, Hungary, 9700
Tudogyogyintezet Torokbalint
Torokbalint, Hungary, 2045
Zala Megyei Korhaz; Dept of Pulmonary Medicine
Zalaegerszeg, Hungary, 8900
Israel
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, Israel, 91031
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Italy
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40139
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli-Venezia Giulia, Italy, 33081
ASST DI MONZA; Oncologia Medica
Monza, Lombardia, Italy, 20900
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piemonte, Italy, 10043
A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.
Verona, Veneto, Italy, 37134
Netherlands
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Catharina-ziekenhuis; Longgeneeskunde en Tuberculose
Eindhoven, Netherlands, 5623 EJ
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700 RB
Russian Federation
Regional Oncology Center
Chelyabinsk, Russian Federation, 454087
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, Russian Federation, 143423
City Oncology Hospital; Chemotherapy Dept
Nizhny Novgorod, Russian Federation, 603000
Leningrad Regional Clinical Hospital
St Petersburg, Russian Federation, 194291
Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery
St. Petersburg, Russian Federation, 189646
Spain
Hospital Nuestra Señora de Sonsoles; servicio de Oncologia
Avila, Spain, 05071
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Madrid, Spain, 28222
Ukraine
Kiev City Clinical Oncology Center
Kiev, Ukraine, 03115
Volyn Regional Oncology Dispensary
Lutsk, Ukraine, 43018
State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
Lviv, Ukraine, 79031
Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept
Simferopol, Ukraine, 95023
Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
Sumy, Ukraine, 40005
Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
Zaporizhzhya, Ukraine, 69040
United Kingdom
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, United Kingdom, GU2 7XX
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, United Kingdom, LE1 5WW
Christie Hospital Nhs Trust; Medical Oncology
Manchester, United Kingdom, M2O 4BX
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01493843     History of Changes
Other Study ID Numbers: GO27912
2011-002893-21 ( EudraCT Number )
Study First Received: December 14, 2011
Last Updated: April 21, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
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 July 21, 2017