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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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pictilisib
Placebo
bevacizumab
carboplatin
paclitaxel
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Alabama Oncology
  • Highlands Oncology Group
  • cCare
  • Kaiser Permanente - Oakland
  • Desert Hematology Oncology Group
  • Kaiser Permanente - Roseville
  • Kaiser Permanente Sacramento Medical Center
  • Southern CA Permanente Med Grp
  • Kaiser Permanente
  • K. Permanente - Santa Clara
  • Stockton Hema Onc Med Grp Inc
  • Kaiser Permanente - Vallejo
  • K. Permanente - Walnut Creek
  • Hematology Oncology PC; Bennett Cancer Center
  • Lynn Regional Cancer Center West
  • Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
  • Advanced Medical Specialties
  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
  • University Cancer & Blood Center, LLC
  • Peachtree Hematology & Oncology Consultants, Pc
  • Georgia Cancer Specialists
  • Hematology-Oncology of Indiana, Pc
  • Franklin Square Hospital
  • Massachusetts General Hospital.
  • Dana Farber Cancer Inst.
  • Beth Israel Deaconess Medical Center
  • Wayne State University; Hemat/Onc, 4HW CRC
  • Nebraska Methodist Hospital
  • Va Sierra Nevada Health Care System
  • San Juan Oncology Associates
  • Roswell Park Cancer Inst.
  • Piedmont Hematology Oncology Associates
  • Gabrail Cancer Center
  • The Christ Hospital
  • Univ Hosp Case Medical Center
  • Center for Biomedical Research LLC
  • The Sarah Cannon Research Inst
  • Vanderbilt
  • University of Texas M.D. Anderson Cancer Center
  • Wellmonth Physician Services
  • Blue Ridge Cancer Care - Roanoke
  • VA Puget Sound Health Care Sys
  • Northwest Medical Specialties
  • Clinica Universitaria Reina Fabiola
  • Instituto FIDES
  • Isis Centro Especializado de Luces; Oncology
  • Royal Prince Alfred Hospital; Sydney Cancer Centre
  • St Vincent'S Hospital
  • Calvary Mater Newcastle; Medical Oncology
  • Flinders Medical Centre; Medical Oncology
  • Royal Hobart Hospital; Medical Oncology
  • Footscray Hospital
  • Royal Melbourne Hospital; Hematology and Medical Oncology
  • Centro de Oncologia da Bahia - CENOB
  • Clinica de Tratamento e Pesquisa Oncologica - Oncotek
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Liga Norte Riograndense Contra O Câncer
  • Santa Casa de Misericordia de Porto Alegre
  • Hospital Mae de Deus
  • Centro de Pesquisas Oncologicas - CEPON
  • Hospital Amaral Carvalho
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Instituto de Oncologia de Sorocaba - CEPOS
  • Mcgill University - Royal Victoria Hospital; Oncology
  • Hopital du Sacre-Coeur
  • Clinica Santa Maria
  • Fundacion Arturo Lopez Perez
  • Instituto Oncologico del sur
  • Hospital Clinico Vina del Mar
  • Hopital Morvan
  • Clinique Victor Hugo; Radiotherapie
  • Clinique Catherine de Sienne; Service de cancérologie
  • Ico Rene Gauducheau; Oncologie
  • Centre Hospitalier de Villefranche sur Saone
  • Institut Gustave Roussy; Departement Oncologie Medicale
  • Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie
  • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
  • Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie
  • St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
  • Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
  • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
  • Orszagos Koranyi TBC es Pulmonologiai Intezet
  • Koch Robert Korhaz
  • Veszprem Megyei Onkormanyzat Tudogyogyintezet
  • Vas Megyei Markusovszky Korhaz ; Pulmonology
  • Tudogyogyintezet Torokbalint
  • Zala Megyei Korhaz; Dept of Pulmonary Medicine
  • Shaare Zedek Medical Center; Oncology Dept
  • Meir Medical Center; Oncology
  • Chaim Sheba Medical Center; Oncology Dept
  • Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • ASST DI MONZA; Oncologia Medica
  • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
  • A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.
  • Amphia Ziekenhuis
  • Catharina-ziekenhuis; Longgeneeskunde en Tuberculose
  • Universitair Medisch Centrum Groningen
  • Regional Oncology Center
  • Moscow city oncology hospital #62 of Moscow Healthcare Department
  • City Oncology Hospital; Chemotherapy Dept
  • Leningrad Regional Clinical Hospital
  • Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery
  • Hospital Nuestra Señora de Sonsoles; servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Kiev City Clinical Oncology Center
  • Volyn Regional Oncology Dispensary
  • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
  • Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept
  • Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
  • Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
  • Royal Surrey County Hospital; St. Lukes Cancer Centre
  • Leicester Royal Infirmary; Dept. of Medical Oncology
  • Christie Hospital Nhs Trust; Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Arm A: 340 mg pictilisib + CP

Arm B: Placebo + CP

Arm C: 340 mg pictilisib + CPB

Arm D: Placebo + CPB

Arm E: 260 mg pictilisib + CPB

Arm F: Placebo + CPB

Arm Description

Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification
PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low

Secondary Outcome Measures

Objective Tumor Response
Objective Tumor Response in Participants with PIK3CA Amplification
Objective Tumor Response in Participants with PTEN Loss/low
Duration of Objective Response (DoR)
DoR in Participants with PIK3CA Amplification
DoR in Participants with PTEN Loss/low
Overall Survival (OS)
OS in Participants with PIK3CA Amplification
OS in Participants with PTEN Loss/low
Percentage of Participants with Adverse Events

Full Information

First Posted
December 14, 2011
Last Updated
April 21, 2017
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01493843
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 20, 2012 (Actual)
Primary Completion Date
March 30, 2016 (Actual)
Study Completion Date
March 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
501 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: 340 mg pictilisib + CP
Arm Type
Experimental
Arm Description
Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P).
Arm Title
Arm B: Placebo + CP
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Arm C: 340 mg pictilisib + CPB
Arm Type
Experimental
Arm Description
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).
Arm Title
Arm D: Placebo + CPB
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Arm E: 260 mg pictilisib + CPB
Arm Type
Experimental
Arm Description
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).
Arm Title
Arm F: Placebo + CPB
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
pictilisib
Other Intervention Name(s)
GDC-0941
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Time Frame
Up to approximately 2.5 years
Title
PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification
Time Frame
Up to approximately 2.5 years
Title
PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low
Time Frame
Up to approximately 2.5 years
Secondary Outcome Measure Information:
Title
Objective Tumor Response
Time Frame
Up to approximately 2.5 years
Title
Objective Tumor Response in Participants with PIK3CA Amplification
Time Frame
Up to approximately 2.5 years
Title
Objective Tumor Response in Participants with PTEN Loss/low
Time Frame
Up to approximately 2.5 years
Title
Duration of Objective Response (DoR)
Time Frame
Up to approximately 2.5 years
Title
DoR in Participants with PIK3CA Amplification
Time Frame
Up to approximately 2.5 years
Title
DoR in Participants with PTEN Loss/low
Time Frame
Up to approximately 2.5 years
Title
Overall Survival (OS)
Time Frame
Up to approximately 2.5 years
Title
OS in Participants with PIK3CA Amplification
Time Frame
Up to approximately 2.5 years
Title
OS in Participants with PTEN Loss/low
Time Frame
Up to approximately 2.5 years
Title
Percentage of Participants with Adverse Events
Time Frame
Up to approximately 4 years

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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