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
NCT ID: NCT01493843
Last Updated: 2017-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
501 participants
INTERVENTIONAL
2012-01-20
2016-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alabama Oncology
Birmingham, Alabama, United States
Highlands Oncology Group
Rogers, Arkansas, United States
cCare
Encinitas, California, United States
Kaiser Permanente - Oakland
Oakland, California, United States
Desert Hematology Oncology Group
Rancho Mirage, California, United States
Kaiser Permanente - Roseville
Roseville, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Southern CA Permanente Med Grp
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
K. Permanente - Santa Clara
Santa Clara, California, United States
Stockton Hema Onc Med Grp Inc
Stockton, California, United States
Kaiser Permanente - Vallejo
Vallejo, California, United States
K. Permanente - Walnut Creek
Walnut Creek, California, United States
Hematology Oncology PC; Bennett Cancer Center
Stamford, Connecticut, United States
Lynn Regional Cancer Center West
Boca Raton, Florida, United States
Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
Fort Myers, Florida, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States
Advanced Medical Specialties
Miami, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Peachtree Hematology & Oncology Consultants, Pc
Atlanta, Georgia, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Hematology-Oncology of Indiana, Pc
Indianapolis, Indiana, United States
Franklin Square Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Wayne State University; Hemat/Onc, 4HW CRC
Detroit, Michigan, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Va Sierra Nevada Health Care System
Reno, Nevada, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Roswell Park Cancer Inst.
Buffalo, New York, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Univ Hosp Case Medical Center
Cleveland, Ohio, United States
Center for Biomedical Research LLC
Knoxville, Tennessee, United States
The Sarah Cannon Research Inst
Nashville, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Wellmonth Physician Services
Bristol, Virginia, United States
Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, United States
VA Puget Sound Health Care Sys
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Clinica Universitaria Reina Fabiola
Córdoba, , Argentina
Instituto FIDES
La Plata, , Argentina
Isis Centro Especializado de Luces; Oncology
Santa Fe, , Argentina
Royal Prince Alfred Hospital; Sydney Cancer Centre
Camperdown, New South Wales, Australia
St Vincent'S Hospital
Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia
Flinders Medical Centre; Medical Oncology
Bedford Park, South Australia, Australia
Royal Hobart Hospital; Medical Oncology
Hobart, Tasmania, Australia
Footscray Hospital
Footscray, Victoria, Australia
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia
Centro de Oncologia da Bahia - CENOB
Salvador, Estado de Bahia, Brazil
Clinica de Tratamento e Pesquisa Oncologica - Oncotek
Brasília, Federal District, Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, Rio de Janeiro, Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Rio Grande do Norte, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, São Paulo, Brazil
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada
Hopital du Sacre-Coeur
Montreal, Quebec, Canada
Clinica Santa Maria
Santiago, , Chile
Fundacion Arturo Lopez Perez
Santiago, , Chile
Instituto Oncologico del sur
Temuco, , Chile
Hospital Clinico Vina del Mar
Viña del Mar, , Chile
Hopital Morvan
Brest, , France
Clinique Victor Hugo; Radiotherapie
Le Mans, , France
Clinique Catherine de Sienne; Service de cancérologie
Nantes, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Centre Hospitalier de Villefranche sur Saone
Villefranche-sur-Saône, , France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, , France
Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie
Bad Berka, , Germany
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting, , Germany
Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie
Großhansdorf, , Germany
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, , Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg, , Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, , Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, , Germany
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, , Hungary
Koch Robert Korhaz
Edelény, , Hungary
Veszprem Megyei Onkormanyzat Tudogyogyintezet
Farkasgyepű, , Hungary
Vas Megyei Markusovszky Korhaz ; Pulmonology
Szombathely, , Hungary
Tudogyogyintezet Torokbalint
Törökbálint, , Hungary
Zala Megyei Korhaz; Dept of Pulmonary Medicine
Zalaegerszeg, , Hungary
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, , Israel
Meir Medical Center; Oncology
Kfar Saba, , Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, , Israel
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, Italy
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piedmont, Italy
A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.
Verona, Veneto, Italy
Amphia Ziekenhuis
Breda, , Netherlands
Catharina-ziekenhuis; Longgeneeskunde en Tuberculose
Eindhoven, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Regional Oncology Center
Chelyabinsk, , Russia
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, , Russia
City Oncology Hospital; Chemotherapy Dept
Nizhny Novgorod, , Russia
Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery
Saint Petersburg, , Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Hospital Nuestra Señora de Sonsoles; servicio de Oncologia
Ávila, , Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Madrid, , Spain
Kiev City Clinical Oncology Center
Kiev, , Ukraine
Volyn Regional Oncology Dispensary
Lutsk, , Ukraine
State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
Lviv, , Ukraine
Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept
Simferopol, , Ukraine
Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
Sumy, , Ukraine
Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
Zaporizhzhya, , Ukraine
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Countries
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Other Identifiers
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2011-002893-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27912
Identifier Type: -
Identifier Source: org_study_id
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