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
Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
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)
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
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
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
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).