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

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 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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: pictilisib; Drug: carboplatin; Drug: paclitaxel; Drug: Placebo; Drug: bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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: 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.; 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.
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 Names: 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.; 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 Names: Avastin
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: 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.; 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 Names: Avastin
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 Names: 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.; 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 Names: Avastin
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: 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.; 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 Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival (PFS)	Up to approximately 2.5 years
PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification	Up to approximately 2.5 years
PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low	Up to approximately 2.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2012
• Primary Completion (Actual): March 30, 2016
• Study Completion (Actual): March 30, 2016

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: GO27912; 2011-002893-21 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No