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Non-Small Cell Lung CancerPhase 2NCT01493843

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 2 study testing pictilisib, bevacizumab and carboplatin in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 120 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
pictilisib, bevacizumab and carboplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
501 participants
Where
120 sitesin 16 countries
Study dates
20 Jan 2012to 30 Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

120 sites in 16 countries.

120 sites in 16 countries

United States44 sites

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Peachtree Hematology & Oncology Consultants, Pc

    Atlanta, Georgia, 30318

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • Franklin Square Hospital

    Baltimore, Maryland, 21237

  • Alabama Oncology

    Birmingham, Alabama, 35211

  • Lynn Regional Cancer Center West

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Inst.

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Wellmonth Physician Services

    Bristol, Virginia, 24201

  • Roswell Park Cancer Inst.

    Buffalo, New York, 14263

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Univ Hosp Case Medical Center

    Cleveland, Ohio, 44106

  • Wayne State University; Hemat/Onc, 4HW CRC

    Detroit, Michigan, 48201

  • cCare

    Encinitas, California, 92024

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Florida Cancer Specialists - Fort Myers (Colonial Center Dr)

    Fort Myers, Florida, 33905

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Hematology-Oncology of Indiana, Pc

    Indianapolis, Indiana, 46260

  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

    Jacksonville, Florida, 32256

  • Center for Biomedical Research LLC

    Knoxville, Tennessee, 37909

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • The Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

  • Vanderbilt

    Nashville, Tennessee, 37232

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Desert Hematology Oncology Group

    Rancho Mirage, California, 92270

  • Va Sierra Nevada Health Care System

    Reno, Nevada, 89502

  • Blue Ridge Cancer Care - Roanoke

    Roanoke, Virginia, 24014

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Kaiser Permanente - Roseville

    Roseville, California, 95661

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Southern CA Permanente Med Grp

    San Diego, California, 92120

  • Kaiser Permanente

    San Francisco, California, 94115

  • K. Permanente - Santa Clara

    Santa Clara, California, 95051

  • VA Puget Sound Health Care Sys

    Seattle, Washington, 98108

  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

    St. Petersburg, Florida, 33705

  • Hematology Oncology PC; Bennett Cancer Center

    Stamford, Connecticut, 06902

  • Stockton Hema Onc Med Grp Inc

    Stockton, California, 95204

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • K. Permanente - Walnut Creek

    Walnut Creek, California, 94596

  • Piedmont Hematology Oncology Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Brazil10 sites

  • Clinica de Tratamento e Pesquisa Oncologica - Oncotek

    Brasília, Federal District, 70390-055

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Liga Norte Riograndense Contra O Câncer

    Natal, Rio Grande do Norte, 59040150

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Centro de Oncologia da Bahia - CENOB

    Salvador, Estado de Bahia, 41820-021

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Instituto de Oncologia de Sorocaba - CEPOS

    Sorocaba, São Paulo, 18030-245

Other trials in Brazil

Germany8 sites

  • Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

    Bad Berka, 99437

  • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie

    Gauting, 82131

  • Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie

    Großhansdorf, 22927

  • St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

    Karlsruhe, 76137

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

    Mainz, 55131

  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

    Regensburg, 93053

  • Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

    Ulm, 89081

  • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

    Villingen-Schwenningen, 78052

Other trials in Germany

Australia7 sites

  • Flinders Medical Centre; Medical Oncology

    Bedford Park, South Australia, 5042

  • Royal Prince Alfred Hospital; Sydney Cancer Centre

    Camperdown, New South Wales, 2050

  • St Vincent'S Hospital

    Darlinghurst, New South Wales, 2010

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Royal Hobart Hospital; Medical Oncology

    Hobart, Tasmania, 7000

  • Royal Melbourne Hospital; Hematology and Medical Oncology

    Parkville, Victoria, 3052

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

Other trials in Australia

France6 sites

  • Hopital Morvan

    Brest, 29200

  • Clinique Victor Hugo; Radiotherapie

    Le Mans, 72015

  • Clinique Catherine de Sienne; Service de cancérologie

    Nantes, 44202

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Centre Hospitalier de Villefranche sur Saone

    Villefranche-sur-Saône, 69655

  • Institut Gustave Roussy; Departement Oncologie Medicale

    Villejuif, 94805

Other trials in France

Hungary6 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121

  • Koch Robert Korhaz

    Edelény, 3780

  • Veszprem Megyei Onkormanyzat Tudogyogyintezet

    Farkasgyepű, 8582

  • Vas Megyei Markusovszky Korhaz ; Pulmonology

    Szombathely, 9700

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

  • Zala Megyei Korhaz; Dept of Pulmonary Medicine

    Zalaegerszeg, 8900

Other trials in Hungary

Ukraine6 sites

  • Kiev City Clinical Oncology Center

    Kiev, 03115

  • Volyn Regional Oncology Dispensary

    Lutsk, 43018

  • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

    Lviv, 79031

  • Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept

    Simferopol, 95023

  • Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

    Sumy, 40005

  • Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

    Zaporizhzhya, 69040

Other trials in Ukraine

Italy5 sites

  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

    Aviano, Friuli Venezia Giulia, 33081

  • Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

    Bologna, Emilia-Romagna, 40139

  • ASST DI MONZA; Oncologia Medica

    Monza, Lombardy, 20900

  • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

    Orbassano, Piedmont, 10043

  • A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

    Verona, Veneto, 37134

Other trials in Italy

Russia5 sites

  • Regional Oncology Center

    Chelyabinsk, 454087

  • Moscow city oncology hospital #62 of Moscow Healthcare Department

    Moscow, 143423

  • City Oncology Hospital; Chemotherapy Dept

    Nizhny Novgorod, 603000

  • Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery

    Saint Petersburg, 189646

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

Other trials in Russia

Spain5 sites

  • Hospital Nuestra Señora de Sonsoles; servicio de Oncologia

    Ávila, 05071

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Barcelona, 08916

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Madrid, 28222

Other trials in Spain

Chile4 sites

  • Clinica Santa Maria

    Santiago, 0

  • Fundacion Arturo Lopez Perez

    Santiago, 7500921

  • Instituto Oncologico del sur

    Temuco, 4810469

  • Hospital Clinico Vina del Mar

    Viña del Mar, 2520612

Other trials in Chile

Argentina3 sites

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004FHP

  • Instituto FIDES

    La Plata, B1900BAJ

  • Isis Centro Especializado de Luces; Oncology

    Santa Fe, 03000

Other trials in Argentina

Israel3 sites

  • Shaare Zedek Medical Center; Oncology Dept

    Jerusalem, 91031

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

Other trials in Israel

Netherlands3 sites

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Catharina-ziekenhuis; Longgeneeskunde en Tuberculose

    Eindhoven, 5623 EJ

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

Other trials in Netherlands

United Kingdom3 sites

  • Royal Surrey County Hospital; St. Lukes Cancer Centre

    Guildford, GU2 7XX

  • Leicester Royal Infirmary; Dept. of Medical Oncology

    Leicester, LE1 5WW

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

Other trials in United Kingdom

Canada2 sites

  • Mcgill University - Royal Victoria Hospital; Oncology

    Montreal, Quebec, H3A 1A1

  • Hopital du Sacre-Coeur

    Montreal, Quebec, J4B 5Z7

Other trials in Canada

About this study

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

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.

Being tested
pictilisib, Placebo, bevacizumab, carboplatin, paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pictilisibDrug

    Also called GDC-0941

    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.

  • PlaceboDrug

    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.

  • bevacizumabDrug

    Also called Avastin

    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.

  • carboplatinDrug

    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.

  • paclitaxelDrug

    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.

Study groups in NCT01493843
Study groupRoleWhat they receive
Arm A: 340 mg pictilisib + CPExperimentalParticipants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P).
Receives: Drug: pictilisib; Drug: carboplatin; Drug: paclitaxel
Arm B: Placebo + CPPlacebo comparatorParticipants 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).
Receives: Drug: Placebo; Drug: carboplatin; Drug: paclitaxel
Arm C: 340 mg pictilisib + CPBExperimentalParticipants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).
Receives: Drug: pictilisib; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel
Arm D: Placebo + CPBPlacebo comparatorParticipants 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).
Receives: Drug: Placebo; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel
Arm E: 260 mg pictilisib + CPBExperimentalParticipants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B).
Receives: Drug: pictilisib; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel
Arm F: Placebo + CPBPlacebo comparatorParticipants 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).
Receives: Drug: Placebo; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Measured: Up to approximately 2.5 years

  2. PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification

    Measured: Up to approximately 2.5 years

  3. PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low

    Measured: Up to approximately 2.5 years

Secondary outcomes (10)

  1. Objective Tumor Response

    Measured: Up to approximately 2.5 years

  2. Objective Tumor Response in Participants with PIK3CA Amplification

    Measured: Up to approximately 2.5 years

  3. Objective Tumor Response in Participants with PTEN Loss/low

    Measured: Up to approximately 2.5 years

  4. Duration of Objective Response (DoR)

    Measured: Up to approximately 2.5 years

  5. DoR in Participants with PIK3CA Amplification

    Measured: Up to approximately 2.5 years

  6. DoR in Participants with PTEN Loss/low

    Measured: Up to approximately 2.5 years

  7. Overall Survival (OS)

    Measured: Up to approximately 2.5 years

  8. OS in Participants with PIK3CA Amplification

    Measured: Up to approximately 2.5 years

  9. OS in Participants with PTEN Loss/low

    Measured: Up to approximately 2.5 years

  10. Percentage of Participants with Adverse Events

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study start20 Jan 2012
  3. Primary completion30 Mar 2016
  4. Study completion30 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493843
Sponsor's protocol ID
GO27912
Other IDs
2011-002893-21
Status last verified
Apr 2017
First submitted
14 Dec 2011
Last updated
25 Apr 2017
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pictilisib, bevacizumab and carboplatin in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 120 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Brazil, Germany, Australia, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to approximately 2.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.

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