Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 37 for:    ALECTINIB

A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03178552
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Alectinib Drug: Atezolizumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin Drug: Gemcitabine Drug: Entrectinib Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cohort A: Alectinib 600 Milligrams (mg)

This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Enrollment to Cohort A is complete.

Drug: Alectinib
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
Other Name: RO5424802

Experimental: Cohort B: Dose Finding Phase (DFP) Alectinib

This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose.

Enrollment to Cohort B is complete.

Drug: Alectinib
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
Other Name: RO5424802

Experimental: Cohort B: Dose Expansion Phase (DEP) Alectinib

This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death.

Enrollment to Cohort B is complete.

Drug: Alectinib
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
Other Name: RO5424802

Experimental: Cohort C: Atezolizumab 1200 mg
This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death.
Drug: Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion Q21D.
Other Name: RO5541267

Active Comparator: Cohort C: Pemetrexed, Cisplatin or Carboplatin
This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care.
Drug: Pemetrexed
Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.

Drug: Cisplatin
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.

Drug: Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Active Comparator: Cohort C: Gemcitabine, Cisplatin or Carboplatin
This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D.
Drug: Cisplatin
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.

Drug: Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Drug: Gemcitabine
Participants will receive gemcitabine 1000 or 1250 mg/m^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).

Experimental: Cohort D: Entrectinib 600 Milligrams (mg)
This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Drug: Entrectinib
Participants will receive entrectinib 600 mg orally QD.
Other Name: RO7102122




Primary Outcome Measures :
  1. Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  2. Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  3. Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  4. Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]

Secondary Outcome Measures :
  1. All Cohorts: Duration of Response as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  2. Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  3. Cohorts A, B and D: PFS as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  4. All Cohorts: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  5. Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  6. All Cohorts: PFS as Assessed by IRF Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  7. All Cohorts: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  8. All Cohorts: Overall Survival [ Time Frame: Baseline up to approximately 6 years ]
  9. All Cohorts: Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 6 years ]
  10. Cohorts A, B and D: Percentage of Participants who Have Shown Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  11. All Cohorts: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  12. Cohort C: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  13. All Cohorts: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30) [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  14. Cohorts A, B and D: Change from Baseline in HRQoL Scores as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  15. All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30 [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  16. Cohorts A, B and D: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  17. All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ]
  18. Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 28 of Cycle 1 (cycle length = 28 days) ]
  19. Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib [ Time Frame: DFP: pre-dose (0 hours [hr]) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
    DFP: Dose-Finding Phase; DEP: Dose-Expanding Phase.

  20. Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
  21. Cohort B: Time to Reach Cmax (Tmax) of Alectinib [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
  22. Cohort B: Half-Life (t1/2) of Alectinib [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
  23. Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
  24. Cohort B: Metabolite to Parent Exposure Ratio for Cmax [ Time Frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days) ]
  25. Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  26. Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on the RECIST v1.1 at Months 6 and 12 [ Time Frame: Months 6, 12 ]
  27. Cohort D: Time to CNS progression as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to CNS progression (up to approximately 6 years) ]
  28. Cohort D: Time to CNS progression as Assessed by the IRF Based on the RECIST v1.1 [ Time Frame: Baseline up to CNS progression (up to approximately 6 years) ]
  29. Cohort D: Intracranial Tumor Response Rate as Assessed by the Investigator Based on the RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
  30. Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30 [ Time Frame: Baseline, every 4 weeks until disease progression, up to approximately 6 years ]
  31. Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20 [ Time Frame: Baseline, every 4 weeks until disease progression, up to approximately 6 years ]
  32. Cohort D: Mean Plasma Concentration of Entrectinib [ Time Frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days). ]
  33. Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5 [ Time Frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days). ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No prior systemic treatment for unresectable stage IIIB or IV NSCLC
  • Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Measurable disease
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Adequate organ function
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Exclusion Criteria:

  • Inability to swallow oral medication
  • Women who are pregnant or lactating
  • Symptomatic, untreated CNS metastases
  • History of malignancy other than NSLCL within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Known human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness
  • Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
  • Inability to comply with other requirements of the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178552


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: BO29554 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
Layout table for location information
United States, California
University of California San Diego Terminated
La Jolla, California, United States, 92093
UC Davis; Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates; (ECHO) Terminated
Norwich, Connecticut, United States, 06360
United States, Florida
SCRI Florida Cancer Specialists South Recruiting
Fort Myers, Florida, United States, 33916
Florida Cancer Specialist, North Region Recruiting
Saint Petersburg, Florida, United States, 33705
United States, Georgia
University Cancer & Blood Center, LLC; Research Withdrawn
Athens, Georgia, United States, 30607
United States, Illinois
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
United States, Kentucky
University of Kentucky; Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
United States, Michigan
University of Michigan Comprehensive Cancer Center Terminated
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Comprehensive Cancer Centers of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cancer Inst. of New Jersey Withdrawn
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Weill Cornell Medical College-New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
United States, Ohio
Ohio State University Terminated
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon HSU Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
St. Luke's University Health network Terminated
Bethlehem, Pennsylvania, United States, 18015
United States, Tennessee
SCRI Tennessee Oncology Chattanooga Active, not recruiting
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology PLLC - Nashville (20th Ave) Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology - South Austin Active, not recruiting
Austin, Texas, United States, 78745
Oncology Consultants PA Withdrawn
Houston, Texas, United States, 77030
United States, Virginia
Virginia Cancer Specialists, PC Terminated
Fairfax, Virginia, United States, 22031
United States, Washington
University of Washington Seattle Cancer Care Alliance Withdrawn
Seattle, Washington, United States, 98195
Argentina
Fundación CENIT para la Investigación en Neurociencias Recruiting
Buenos Aires, Argentina, C1125ABD
Hospital Italiano Recruiting
Buenos Aires, Argentina, C1181ACH
Hospital Britanico de Buenos Aires Recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
Centro Oncologico Riojano Integral (CORI) Recruiting
La Rioja, Argentina, F5300COE
Australia, New South Wales
Royal North Shore Hospital; Department of Medical Oncology Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Prince Charles Hospital; Oncology Dept. Recruiting
Chermside, Queensland, Australia, 4032
Australia, South Australia
Ashford Cancer Center Research Recruiting
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Austin Hospital; Medical Oncology Recruiting
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Sir Charles Gairdner Hospital Terminated
Nedlands, Western Australia, Australia, 6009
Belgium
UZ Brussel Active, not recruiting
Brussel, Belgium, 1090
Cliniques Universitaires St-Luc Recruiting
Bruxelles, Belgium, 1200
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Brazil
INCA 1- Instituto Nacional de Câncer Recruiting
Rio de Janeiro, RJ, Brazil, 20231-050
Associacao Hospital de Caridade Ijui; Departamento De Oncologia Recruiting
Ijui, RS, Brazil, 98700-000
Hospital Sao Lucas - PUCRS Recruiting
Porto Alegre, RS, Brazil, 90610-000
Instituto do Cancer do Estado de Sao Paulo - ICESP Recruiting
Sao Paulo, SP, Brazil, 01246-000
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba; Department of Medical Oncology Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials Recruiting
Barrie, Ontario, Canada, L4M 6M2
William Osler Health System Brampton Civic Hospital Recruiting
Brampton, Ontario, Canada, L6R 3J7
London Health Sciences Centre · Victoria Hospital; Department of Medicine Recruiting
London, Ontario, Canada, N6A 5W9
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital; Sir Mortimer B. Davis Recruiting
Montreal, Quebec, Canada, H2W 1S6
IUCPQ (Hôpital Laval) Active, not recruiting
Quebec City, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Saskatoon Cancer Agency Recruiting
Saskatoon, Saskatchewan, Canada, SK S7N 4H4
Chile
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas Recruiting
Recoleta, Chile, 8420383
Costa Rica
Clinica CIMCA Recruiting
San Jose, Costa Rica, 10103
France
Institut Bergonie CLCC Bordeaux Recruiting
Bordeaux, France, 33000
Centre Francois Baclesse; Radiologie Active, not recruiting
Caen, France, 14076
Centre Oscar Lambret Recruiting
Lille, France, 59020
Centre Léon Bérard Recruiting
Lyon, France, 69373
Hopital Caremeau; Pneumologie Recruiting
Nimes, France, 30029
Hopital Bichat Claude Bernard; Oncologie Serv. Recruiting
Paris, France, 75018
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75908
Hopital Tenon; Oncologie Radiotherapie Recruiting
Paris, France, 75970
CHU Poitiers Recruiting
Poitiers, France, 86021
Hopital Pontchaillou Active, not recruiting
Rennes, France, 35033
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique Recruiting
Toulouse cedex 9, France, 31100
Hopital Bretonneau; Pneumologie Oncologie Recruiting
Tours, France, 37044
Hopital Robert Schuman; Pneumologie Recruiting
Vantoux, France, 57070
Germany
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09116
Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie Terminated
Düsseldorf, Germany, 40225
Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung) Recruiting
Essen, Germany, 45122
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie Recruiting
Esslingen, Germany, 73730
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie Recruiting
Gauting, Germany, 82131
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie Active, not recruiting
Gerlingen, Germany, 70839
Thoraxklinik Heidelberg gGmbH Recruiting
Heidelberg, Germany, 69126
HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed Active, not recruiting
Wiesbaden, Germany, 65199
Hong Kong
Pamela Youde Nethersole Eastern Hospital Withdrawn
Hong Kong, Hong Kong, Chai Wan
Queen Mary Hospital; Medicine & Respiratory Recruiting
Hong Kong, Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc Recruiting
Shatin, Hong Kong
Israel
Soroka Medical Center; Oncology Dept Recruiting
Beer Sheva, Israel, 8410100
Rambam Health Care Campus; Oncology Recruiting
Haifa, Israel, 3109601
Meir Medical Center; Oncology Recruiting
Kfar-Saba, Israel, 4428164
Rabin MC; Davidof Center - Oncology Institute Recruiting
Petach Tikva, Israel, 4941492
Chaim Sheba Medical Center; Oncology Dept Recruiting
Ramat Gan, Israel, 52620-00
Sourasky / Ichilov Hospital; Dept. of Oncology Recruiting
Tel Aviv, Israel, 6423906
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale Recruiting
Napoli, Campania, Italy, 80131
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Recruiting
Meldola, Emilia-Romagna, Italy, 47014
Irccs Centro Di Riferimento Oncologico (CRO) Recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
Azienda Ospedaliera San Camillo Forlanini Recruiting
Roma, Lazio, Italy, 00151
Asst Papa Giovanni XXIII; Oncologia Medica Recruiting
Bergamo, Lombardia, Italy, 24127
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona Recruiting
Cremona, Lombardia, Italy, 26100
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia Recruiting
Milano, Lombardia, Italy, 20141
Asst Di Monza Recruiting
Monza, Lombardia, Italy, 20900
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica Recruiting
Orbassano (TO), Piemonte, Italy, 10043
Japan
Fujita Health University Hospital Recruiting
Aichi, Japan, 470-1192
National Cancer Center Hospital East Recruiting
Chiba, Japan, 277-8577
Shikoku Cancer Center Recruiting
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Medical Center Recruiting
Fukuoka, Japan, 810-8563
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Kanazawa University Hospital Recruiting
Ishikawa, Japan, 920-8641
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
University Hospital Kyoto Prefectural University of Medicine Recruiting
Kyoto, Japan, 602-8566
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Sendai Kousei Hospital Recruiting
Miyagi, Japan, 980-0873
Tohoku University Hospital Recruiting
Miyagi, Japan, 980-8574
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8520
Niigata Cancer Center Hospital Recruiting
Niigata, Japan, 951-8566
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Kindai University Hospital Recruiting
Osaka, Japan, 589-8511
Saga University Hospital Recruiting
Saga, Japan, 849-8501
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 41109340
Juntendo University Hospital Recruiting
Tokyo, Japan, 113-8431
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Recruiting
Tokyo, Japan, 113-8677
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan, 135-8550
Kyorin University Hospital Recruiting
Tokyo, Japan, 181-8611
Wakayama Medical University Hospital Recruiting
Wakayama, Japan, 641-8509
National Hospital Organization Yamaguchi - Ube Medical Center Recruiting
Yamaguchi, Japan, 775-0241
Korea, Republic of
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Yonsei University Health System/Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Mexico
Health Pharma Professional Research Recruiting
CD Mexico, Mexico CITY (federal District), Mexico, 03810
Oncologico Potosino Recruiting
San Luis Potosí, SAN LUIS Potosi, Mexico, 78250
AVIX Investigación Clínica S.C Recruiting
Monterrey, Mexico, 64710
Hospital Angeles Tijuana Recruiting
Tijuana, Mexico, 22010
Netherlands
UMCG Withdrawn
NL -groningen, Netherlands, 9700 RB
Erasmus MC Withdrawn
Rotterdam, Netherlands, 3015 GD
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Panama
Hemato Oncología de Panamá Especializada Recruiting
Panama City, Panama, 0801
Peru
Hospital Nacional Edgardo Rebagliati Martins; Oncologia Recruiting
Lima, Peru, 11
Instituto Nacional de Enfermedades Neoplasicas Recruiting
Lima, Peru, 15038
Clinica Ricardo Palma Recruiting
San Isidro, Peru, Lima 27
Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii Recruiting
Gdansk, Poland, 80-214
Krakowski Szpital Specjalistyczny im.Jana Pawla II Recruiting
Krakow, Poland, 31-202
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc Recruiting
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Recruiting
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Recruiting
Poznan, Poland, 60-569
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej Recruiting
Warszawa, Poland, 02-781
Russian Federation
Moscow City Oncology Hospital #62 Active, not recruiting
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Principal Military Clinical Hospital n.a. N.N. Burdenko Recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 105229
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Not yet recruiting
Moscow, Russian Federation, 115478
Clinical Oncology Dispensary; Chemotherapy Active, not recruiting
Omsk, Russian Federation, 644013
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Recruiting
Saint-Petersburg, Russian Federation, 197758
Saint-Petersburg City Clinical Oncology Dispensary Recruiting
St Petersburg, Russian Federation, 197022
Serbia
Clinical Center of Serbia Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska Kosa Recruiting
Belgrade, Serbia, 11080
Clinical Center Nis Recruiting
NIS, Serbia, 18000
Institute for Pulmonary Diseases of Vojvodina Recruiting
Sremska Kamenica, Serbia, 21204
Singapore
National University Hospital; National University Cancer Institute, Singapore (NCIS) Recruiting
Singapore, Singapore, 119228
National Cancer Centre; Medical Oncology Recruiting
Singapore, Singapore, 169610
Spain
Insititut Catala D'Oncologia Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08908
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Clinica Universitaria de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Hospital General Univ. de Alicante Recruiting
Alicante, Spain, 03010
Hospital Universitari Vall d'Hebron; Oncology Recruiting
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología Recruiting
Barcelona, Spain, 08036
ICO Badalona - Hospital Germans Trias i Pujol Recruiting
Barcelona, Spain, 08916
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Recruiting
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia Recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Centro Integral Oncologico Clara Campal; Servicio de Oncología Recruiting
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro; Servicio de Oncologia Recruiting
Madrid, Spain, 28222
Hospital Quiron de Madrid; Servicio de Oncologia Recruiting
Madrid, Spain, 28223
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Recruiting
Malaga, Spain, 29010
Hospital Universitario Virgen del Rocio; Servicio de Oncologia Recruiting
Sevilla, Spain, 41013
Hospital Clínico Universitario de Valencia; Servicio de Oncología Recruiting
Valencia, Spain, 46010
Switzerland
CHUV; Departement d'Oncologie Not yet recruiting
Lausanne, Switzerland, 1011
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie Not yet recruiting
Zürich, Switzerland, 8091
Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine Recruiting
Kaohsiung, Taiwan, 83301
National Taiwan Uni Hospital; Internal Medicine Recruiting
Taipei, Taiwan, 100
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology Recruiting
Taipei, Taiwan, 112
Chang Gung Medical Foundation - Linkou; Chest Dept Recruiting
Taoyuan, Taiwan, 333
Thailand
Chulalongkorn Hospital; Medical Oncology Recruiting
Bangkok, Thailand, 10330
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Recruiting
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Active, not recruiting
Bangkok, Thailand, 10700
Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine Active, not recruiting
Hat Yai, Thailand, 90110
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Recruiting
Adana, Turkey, 01250
Akdeniz University Medical Faculty; Medical Oncology Department Recruiting
Antalya, Turkey, 07070
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department Not yet recruiting
Edirne, Turkey, 22770
Medipol University MF; Oncology Department Recruiting
Istanbul, Turkey, 34214
Marmara Uni Faculty of Medicine; Medical Oncology Recruiting
Istanbul, Turkey, 34890
Medikal Park Izmir Hospital Recruiting
Karşıyaka, Turkey, 35575
Hacettepe Uni Medical Faculty Hospital; Oncology Dept Recruiting
Sıhhiye, Ankara, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03178552     History of Changes
Other Study ID Numbers: BO29554
2017-000076-28 ( EudraCT Number )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Gemcitabine
Carboplatin
Pemetrexed
Atezolizumab
Entrectinib
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors