An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

February 2, 2023 updated by: Bristol-Myers Squibb

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
541

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Local Institution - 0050
      • Cordoba, Argentina, 5000
        • Local Institution - 0048
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1880
        • Local Institution - 0051
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution - 0049
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
        • Local Institution - 0052
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0090
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution - 0091
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0071
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Local Institution - 0072
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0104
  • Austria
      • Wels, Austria, 4600
        • Local Institution - 0088
      • Wien, Austria, 1090
        • Local Institution - 0087
  • Belgium
      • Brussels, Belgium, 1090
        • Local Institution - 0044
      • Edegem, Belgium, 2650
        • Local Institution - 0055
      • Gent, Belgium, 9000
        • Local Institution - 0056
      • Leuven, Belgium, 3000
        • Local Institution - 0062
  • Brazil
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Local Institution - 0134
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Local Institution - 0133
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14780-070
        • Local Institution - 0135
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution - 0086
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution - 0115
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0113
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Local Institution - 0110
      • Rimouski, Quebec, Canada, G5L 5T1
        • Local Institution - 0109
  • Czechia
      • Olomouc, Czechia, 779 00
        • Local Institution - 0059
      • Ostrava - Poruba, Czechia, 708 52
        • Local Institution - 0061
      • Praha 8, Czechia, 180 81
        • Local Institution - 0058
      • Usti nad Labem, Czechia, 401 13
        • Local Institution - 0060
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0120
      • Tampere, Finland, 33521
        • Local Institution - 0119
      • Vaasa, Finland, 65130
        • Local Institution - 0118
  • France
      • Caen, France, 14000
        • Local Institution - 0123
      • Lille, France, 59000
        • Local Institution - 0105
      • Marseille Cedex 20, France, 13915
        • Local Institution - 0102
      • Pontoise Cedex, France, 95303
        • Local Institution - 0167
      • Rennes Cedex 9, France, 35033
        • Local Institution - 0100
      • Strasbourg, France, 67090
        • Local Institution - 0140
  • Germany
      • Bamberg, Germany, 96049
        • Local Institution - 0074
      • Grosshansdorf, Germany, 22927
        • Local Institution - 0065
      • Heidelberg, Germany, 69126
        • Local Institution - 0064
      • Koeln, Germany, 50937
        • Local Institution - 0063
      • Stuttgart, Germany, 70376
        • Local Institution - 0066
      • Wiesbaden, Germany, 65199
        • Local Institution - 0092
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 0075
    • Creta
      • Heraklion, Creta, Greece, 71110
        • Local Institution - 0073
  • Hungary
      • Budapest, Hungary, 1121
        • Local Institution - 0126
      • Debrecen, Hungary, 4032
        • Local Institution - 0116
      • Matrahaza, Hungary, 3233
        • Local Institution - 0094
  • Italy
      • Avellino, Italy, 83100
        • Local Institution - 0084
      • Livorno, Italy, 57100
        • Local Institution - 0079
      • Milano, Italy, 20141
        • Local Institution - 0143
      • Napoli, Italy, 80131
        • Local Institution - 0142
      • Perugia, Italy, 06132
        • Local Institution - 0083
      • Terni, Italy, 05100
        • Local Institution - 0082
  • Japan
      • Akashi, Hyogo, Japan, 673-8558
        • Local Institution - 0159
      • Ota, Gunma, Japan, 3738550
        • Local Institution - 0162
      • Sapporo, Hokkaido, Japan, 062-0931
        • Local Institution - 0165
      • Tokyo, Japan, 1358550
        • Local Institution - 0160
      • Wakayama, Japan, 641-8510
        • Local Institution - 0158
    • Aichi
      • Nagoya, Aichi, Japan, 4600001
        • Local Institution - 0146
      • Nagoya-shi, Aichi, Japan, 4640021
        • Local Institution - 0161
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 7910280
        • Local Institution - 0148
    • Hyogo
      • Kobe City, Hyogo, Japan, 6500047
        • Local Institution - 0153
    • Miyagi
      • Natori-shi, Miyagi, Japan, 9811293
        • Local Institution - 0144
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Local Institution - 0151
    • Osaka
      • Habikino-shi, Osaka, Japan, 5638588
        • Local Institution - 0166
      • Miyakojima-ku, Osaka, Japan, 534-0021
        • Local Institution - 0147
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Local Institution - 0145
      • Sakai, Osaka, Japan, 591-8555
        • Local Institution - 0152
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution - 0150
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution - 0149
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0154
  • Korea, Republic of
      • Gangnam-gu, Korea, Republic of, 06351
        • Local Institution - 0155
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 0164
      • Seoul, Korea, Republic of
        • Local Institution - 0163
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution - 0117
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Local Institution - 0122
    • Yucatan
      • Merida, Yucatan, Mexico, 97133
        • Local Institution - 0124
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0045
      • Groningen, Netherlands, 9700RB
        • Local Institution - 0057
      • Rotterdam, Netherlands, 3014 GD
        • Local Institution - 0046
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0114
      • Krakow, Poland, 31-202
        • Local Institution - 0131
      • Lodz, Poland, 93-513
        • Local Institution - 0139
      • Warszawa, Poland, 02-781
        • Local Institution - 0089
      • Wodzislaw Slaski, Poland, 44-300
        • Local Institution - 0093
  • Romania
      • Cluj Napoca, Romania, 400015
        • Local Institution - 0068
      • Cluj-napoca, Romania, 400352
        • Local Institution - 0067
      • Ploiesti, Romania, 100337
        • Local Institution - 0069
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0040
      • Las Palmas De Gran Canaria, Spain, 35016
        • Local Institution - 0041
      • Madrid, Spain, 28050
        • Local Institution - 0047
      • Malaga, Spain, 29010
        • Local Institution - 0042
      • Sevilla, Spain, 41013
        • Local Institution - 0039
      • Valencia, Spain, 46014
        • Local Institution - 0043
  • Sweden
      • Stockholm, Sweden, 171 76
        • Local Institution - 0127
      • Uppsala, Sweden, 751 85
        • Local Institution - 0125
  • Switzerland
      • Chur, Switzerland, 7000
        • Local Institution - 0076
      • Lausanne, Switzerland, 1011
        • Local Institution - 0077
      • Zuerich, Switzerland, 8091
        • Local Institution - 0078
  • Taiwan
      • Taipei, Taiwan, 11217
        • Local Institution - 0157
  • Turkey
      • Kayseri, Turkey, 38039
        • Local Institution - 0130
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, N18 1QX
        • Local Institution - 0098
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4XB
        • Local Institution - 0097
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS9 7TF
        • Local Institution - 0053
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, Inc.
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Tucson, Arizona, United States, 85704
        • Local Institution - 0034
    • California
      • Stanford, California, United States, 94305-5826
        • Local Institution - 0016
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado Hosp
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0020
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution - 0030
      • Ocala, Florida, United States, 34471
        • Local Institution - 0033
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0010
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Center, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60612-3841
        • Local Institution - 0037
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Local Institution - 0014
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Crescent City Research Consortium, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0024
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0036
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0070
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Local Institution - 0005
      • New York, New York, United States, 10016
        • Local Institution - 0009
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7305
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0003
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0012
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0027
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0007
      • Philadelphia, Pennsylvania, United States, 19111
        • Local Institution - 0002
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0054
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0018
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0011
      • Greenville, South Carolina, United States, 29601
        • Local Institution - 0038
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Local Institution - 0008
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution - 0006
      • Houston, Texas, United States, 77030
        • Local Institution - 0023
      • San Antonio, Texas, United States, 78212
        • Cancer Centers of South Texas
    • Washington
      • Yakima, Washington, United States, 98902
        • Local Institution - 0029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
  • Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
  • PD-L1+ on immunohistochemistry testing performed by central lab
  • Men and women, ages ≥ 18 years of age

Exclusion Criteria:

  • Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
  • Known anaplastic lymphoma kinase (ALK) translocations
  • Untreated central nervous system (CNS) metastases
  • Previous malignancies
  • Active, known or suspected autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Nivolumab subjects
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Active Comparator: Arm B: Investigator's Choice Chemotherapy

Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first

Squamous subjects:

  • Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or
  • Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or
  • Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle

Non-Squamous subjects:

  • Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle
  • Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle

Optional crossover:

  • Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Cisplatin
Other Names:
  • Platinol
Drug: Pemetrexed
Other Names:
  • Alimta
Drug: Carboplatin
Other Names:
  • Paraplatin
Drug: Paclitaxel
Other Names:
  • Taxol
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival in All Randomized Participants
Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.
From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
Disease-related Symptom Improvement Rate by Week 12
Time Frame: From date of randomization to week 12
The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.
From date of randomization to week 12
Overall Survival in Participants With PD-L1 Expression >= 5%
Time Frame: From date of randomization to date of death (up to approximately 89 months)
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
From date of randomization to date of death (up to approximately 89 months)
Overall Survival in All Randomized Participants
Time Frame: From date of randomization to date of death (up to approximately 89 months)
Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.
From date of randomization to date of death (up to approximately 89 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-026
  • 2012-004502-93 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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