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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002893-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 340 mg pictilisib + CP | Experimental | Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). |
|
| Arm B: Placebo + CP | Placebo Comparator | 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 C: 340 mg pictilisib + CPB | Experimental | 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 D: Placebo + CPB | Placebo Comparator | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pictilisib | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35211 | United States | ||
| Highlands Oncology Group |
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|
| Arm E: 260 mg pictilisib + CPB | Experimental | 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 F: Placebo + CPB | Placebo Comparator | 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). |
|
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| Placebo | Drug | 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 | Drug | 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. |
|
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| carboplatin | Drug | 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 | Drug | 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. |
|
| 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 |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| cCare | Encinitas | California | 92024 | United States |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | United States |
| Desert Hematology Oncology Group | Rancho Mirage | California | 92270 | United States |
| Kaiser Permanente - Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | United States |
| Southern CA Permanente Med Grp | San Diego | California | 92120 | United States |
| Kaiser Permanente | San Francisco | California | 94115 | United States |
| K. Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Stockton Hema Onc Med Grp Inc | Stockton | California | 95204 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| K. Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Hematology Oncology PC; Bennett Cancer Center | Stamford | Connecticut | 06902 | United States |
| Lynn Regional Cancer Center West | Boca Raton | Florida | 33486 | United States |
| Florida Cancer Specialists - Fort Myers (Colonial Center Dr) | Fort Myers | Florida | 33905 | United States |
| Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida | 32256 | United States |
| Advanced Medical Specialties | Miami | Florida | 33176 | United States |
| Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | St. Petersburg | Florida | 33705 | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Peachtree Hematology & Oncology Consultants, Pc | Atlanta | Georgia | 30318 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | United States |
| Hematology-Oncology of Indiana, Pc | Indianapolis | Indiana | 46260 | United States |
| Franklin Square Hospital | Baltimore | Maryland | 21237 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Wayne State University; Hemat/Onc, 4HW CRC | Detroit | Michigan | 48201 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Va Sierra Nevada Health Care System | Reno | Nevada | 89502 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Roswell Park Cancer Inst. | Buffalo | New York | 14263 | United States |
| Piedmont Hematology Oncology Associates | Winston-Salem | North Carolina | 27103 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Univ Hosp Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Center for Biomedical Research LLC | Knoxville | Tennessee | 37909 | United States |
| The Sarah Cannon Research Inst | Nashville | Tennessee | 37203 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Wellmonth Physician Services | Bristol | Virginia | 24201 | United States |
| Blue Ridge Cancer Care - Roanoke | Roanoke | Virginia | 24014 | United States |
| VA Puget Sound Health Care Sys | Seattle | Washington | 98108 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Clinica Universitaria Reina Fabiola | Córdoba | X5004FHP | Argentina |
| Instituto FIDES | La Plata | B1900BAJ | Argentina |
| Isis Centro Especializado de Luces; Oncology | Santa Fe | 03000 | Argentina |
| Royal Prince Alfred Hospital; Sydney Cancer Centre | Camperdown | New South Wales | 2050 | Australia |
| St Vincent'S Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Flinders Medical Centre; Medical Oncology | Bedford Park | South Australia | 5042 | Australia |
| Royal Hobart Hospital; Medical Oncology | Hobart | Tasmania | 7000 | Australia |
| Footscray Hospital | Footscray | Victoria | 3011 | Australia |
| Royal Melbourne Hospital; Hematology and Medical Oncology | Parkville | Victoria | 3052 | Australia |
| Centro de Oncologia da Bahia - CENOB | Salvador | Estado de Bahia | 41820-021 | Brazil |
| Clinica de Tratamento e Pesquisa Oncologica - Oncotek | Brasília | Federal District | 70390-055 | Brazil |
| Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Liga Norte Riograndense Contra O Câncer | Natal | Rio Grande do Norte | 59040150 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital Mae de Deus | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Centro de Pesquisas Oncologicas - CEPON | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Instituto de Oncologia de Sorocaba - CEPOS | Sorocaba | São Paulo | 18030-245 | Brazil |
| Mcgill University - Royal Victoria Hospital; Oncology | Montreal | Quebec | H3A 1A1 | Canada |
| Hopital du Sacre-Coeur | Montreal | Quebec | J4B 5Z7 | Canada |
| Clinica Santa Maria | Santiago | 0 | Chile |
| Fundacion Arturo Lopez Perez | Santiago | 7500921 | Chile |
| Instituto Oncologico del sur | Temuco | 4810469 | Chile |
| Hospital Clinico Vina del Mar | Viña del Mar | 2520612 | Chile |
| Hopital Morvan | Brest | 29200 | France |
| Clinique Victor Hugo; Radiotherapie | Le Mans | 72015 | France |
| Clinique Catherine de Sienne; Service de cancérologie | Nantes | 44202 | France |
| Ico Rene Gauducheau; Oncologie | Saint-Herblain | 44805 | France |
| Centre Hospitalier de Villefranche sur Saone | Villefranche-sur-Saône | 69655 | France |
| Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | 94805 | France |
| Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie | Bad Berka | 99437 | Germany |
| Asklepios-Fachkliniken Muenchen-Gauting; Onkologie | Gauting | 82131 | Germany |
| Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie | Großhansdorf | 22927 | Germany |
| St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie | Karlsruhe | 76137 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie | Mainz | 55131 | Germany |
| Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie | Regensburg | 93053 | Germany |
| Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo. | Ulm | 89081 | Germany |
| Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie | Villingen-Schwenningen | 78052 | Germany |
| Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest | 1121 | Hungary |
| Koch Robert Korhaz | Edelény | 3780 | Hungary |
| Veszprem Megyei Onkormanyzat Tudogyogyintezet | Farkasgyepű | 8582 | Hungary |
| Vas Megyei Markusovszky Korhaz ; Pulmonology | Szombathely | 9700 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Zala Megyei Korhaz; Dept of Pulmonary Medicine | Zalaegerszeg | 8900 | Hungary |
| Shaare Zedek Medical Center; Oncology Dept | Jerusalem | 91031 | Israel |
| Meir Medical Center; Oncology | Kfar Saba | 4428164 | Israel |
| Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | 5262100 | Israel |
| Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica | Bologna | Emilia-Romagna | 40139 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| ASST DI MONZA; Oncologia Medica | Monza | Lombardy | 20900 | Italy |
| Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico | Orbassano | Piedmont | 10043 | Italy |
| A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U. | Verona | Veneto | 37134 | Italy |
| Amphia Ziekenhuis | Breda | 4818 CK | Netherlands |
| Catharina-ziekenhuis; Longgeneeskunde en Tuberculose | Eindhoven | 5623 EJ | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9700 RB | Netherlands |
| Regional Oncology Center | Chelyabinsk | 454087 | Russia |
| Moscow city oncology hospital #62 of Moscow Healthcare Department | Moscow | 143423 | Russia |
| City Oncology Hospital; Chemotherapy Dept | Nizhny Novgorod | 603000 | Russia |
| Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery | Saint Petersburg | 189646 | Russia |
| Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Hospital Nuestra Señora de Sonsoles; servicio de Oncologia | Ávila | 05071 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Barcelona | 08916 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Madrid | 28222 | Spain |
| Kiev City Clinical Oncology Center | Kiev | 03115 | Ukraine |
| Volyn Regional Oncology Dispensary | Lutsk | 43018 | Ukraine |
| State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department | Lviv | 79031 | Ukraine |
| Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept | Simferopol | 95023 | Ukraine |
| Sumy Reg. Clin. Oncological Dispensary; Thoracall Department | Sumy | 40005 | Ukraine |
| Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University | Zaporizhzhya | 69040 | Ukraine |
| Royal Surrey County Hospital; St. Lukes Cancer Centre | Guildford | GU2 7XX | United Kingdom |
| Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | LE1 5WW | United Kingdom |
| Christie Hospital Nhs Trust; Medical Oncology | Manchester | M2O 4BX | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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