A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy

September 6, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.

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.
643

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

  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30150-281
    • RO
      • Ijuí, RO, Brazil, 98700-000
    • RS
      • Lajeado, RS, Brazil, 95900-000
      • Porto Alegre, RS, Brazil, 90035-003
      • Porto Alegre, RS, Brazil, 90430-090
      • Porto Alegre, RS, Brazil, 90020-090
      • Porto Alegre, RS, Brazil, 90470340
    • SC
      • Florianopolis, SC, Brazil, 88034-000
    • SP
      • Santo André, SP, Brazil, 09060-650
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
      • Haskovo, Bulgaria, 6300
      • Plovdiv, Bulgaria, 4004
      • Ruse, Bulgaria, 7000
      • Sofia, Bulgaria, 1756
      • Sofia, Bulgaria, 1784
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1303
      • Varna, Bulgaria, 9010
  • Canada
      • Quebec, Canada, G1V 4G5
    • Ontario
      • Windsor, Ontario, Canada, N8W 2X3
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
  • China
      • Beijing, China, 100730
      • Beijing, China, 100142
      • Changchun, China, 130012
      • Fuzhou, China, 350014
      • Guangzhou, China
      • Guangzhou, China, 510515
      • Harbin, China, 150081
      • Shanghai, China, 200433
      • Shanghai, China, 200030
      • Shantou, China, 515041
      • Shenyang, China, 110001
      • Suzhou, China, 215004
      • Tianjin, China, 300060
      • Wuhan, China, 430071
      • Xi'an, China, 710061
  • Czech Republic
      • Ceske Budejovice, Czech Republic, 370 87
      • Jindrichuv Hradec, Czech Republic, 377 01
      • Nymburk, Czech Republic, 288 01
      • Ostrava - Poruba, Czech Republic, 708 52
      • Praha, Czech Republic, 150 06
      • Praha 8, Czech Republic, 180 81
      • Tabor, Czech Republic, 390 03
  • France
      • Bayonne, France, 64109
      • Compiegne, France, 60321
      • Gap, France, 05007
      • Libourne, France, 33505
      • Lille, France, 59020
      • Nantes, France, 44202
      • St Brieuc, France, 22027
      • Villefranche-sur-Saone, France, 69655
  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1121
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1145
      • Deszk, Hungary, 6772
      • Farkasgyepu, Hungary, 8582
      • Gyor, Hungary, 9024
      • Gyula, Hungary, 5703
      • Matrahaza, Hungary, 3233
      • Miskolc, Hungary, 3526
      • Szolnok, Hungary, 5000
      • Székesfehérvár, Hungary, 8000
      • Torokbalint, Hungary, 2045
      • Zalaegerszeg, Hungary, 8900
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Parma, Emilia-Romagna, Italy, 43100
    • Lazio
      • Roma, Lazio, Italy, 00144
      • Roma, Lazio, Italy, 00168
      • Roma, Lazio, Italy, 00151
    • Lombardia
      • Legnago, Lombardia, Italy, 37045
      • Treviglio, Lombardia, Italy, 24047
    • Puglia
      • S. Giovanni Rotondo, Puglia, Italy, 71013
    • Toscana
      • Livorno, Toscana, Italy, 57124
      • Pisa, Toscana, Italy, 56100
    • Veneto
      • Verona, Veneto, Italy, 37134
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul, Korea, Republic of, 150-713
      • Seoul, Korea, Republic of, 06351
      • Seoul, Korea, Republic of, 03722
      • Suwon, Korea, Republic of, 442-723
  • Latvia
      • Daugavpils, Latvia, 5417
      • Riga, Latvia, LV1002
      • Riga, Latvia, LV-1079
  • Lithuania
      • Kaunas, Lithuania, 50009
      • Vilnius, Lithuania, 08660
  • Netherlands
      • Arnhem, Netherlands, 6800 TA
      • Heerlen, Netherlands, 6419 PC
      • Hoorn, Netherlands, 1625 HV
      • Sittard-Geleen, Netherlands, 6162 BG
      • Zutphen, Netherlands, 7207 AE
  • Poland
      • Brzozów, Poland, 36-200
      • Krakow, Poland, 31-115
      • Poznan, Poland, 60-569
      • Wodzislaw Slaski, Poland, 44-300
      • Zamosc, Poland, 22-400
  • Romania
      • Baia Mare, Romania, 430031
      • Braila, Romania, 810325
      • Brasov, Romania, 500152
      • Brasov, Romania, 500091
      • Bucuresti, Romania, 022328
      • Bucuresti, Romania, 010976
      • Cluj-Napoca, Romania, 400058
      • Cluj-Napoca, Romania, 400015
      • Cluj-Napoca, Romania, 400132
      • Oradea, Romania, 410167
      • Ploiesti, Romania, 100337
      • Targu-Mures, Romania, 540136
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
      • Bardejov, Slovakia, 085 01
      • Kosice, Slovakia, 04001
      • Nove Zamky, Slovakia, 940 02
      • Poprad, Slovakia, 058 01
      • Rimavska Sobota, Slovakia, 97901
  • South Africa
      • Cape Town, South Africa, 7570
      • Cape Town, South Africa, 7700
      • George, South Africa, 6530
      • Port Elizabeth, South Africa, 6045
      • Pretoria, South Africa, 0002
  • Taiwan
      • Kaohsiung, Taiwan, 00833
      • Taichung, Taiwan, 40447
      • Taichung, Taiwan, 40705
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 112
      • Taipei, Taiwan, 00112
      • Taipei, Taiwan, 11490
  • Thailand
      • Bangkok, Thailand, 10700
      • Hat Yai, Thailand, 90110
      • Muang, Thailand, 50200
      • Muang, Thailand, 57000
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
      • Donetsk, Ukraine, 83092
      • Kharkiv, Ukraine, 61024
      • Kirovograd, Ukraine, 25011
      • Kyiv, Ukraine, 03115
      • Kyiv, Ukraine, 03022
      • Kyiv, Ukraine, 04107
      • Lutsk, Ukraine, 63000
      • Sumy, Ukraine, 40005
      • Uzhgorod, Ukraine, 88000
      • Vinnytsya, Ukraine, 21029
      • Zaporizhzhya, Ukraine, 69040
  • United States
    • California
      • Gilroy, California, United States, 95020
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Missouri
      • Kansas City, Missouri, United States, 64132
    • Montana
      • Missoula, Montana, United States, 59802
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • Ohio
      • Dayton, Ohio, United States, 45420
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Washington
      • Spokane, Washington, United States, 99218
      • Tacoma, Washington, United States, 98405

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:

  • Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
  • Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
  • Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to [≤] 28 days prior to randomization)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
  • Participants whose tumors harbor an EGFR-activating mutation
  • Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
  • Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
  • Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
  • Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
  • Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
  • Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
  • Any inflammatory changes of the surface of the eye

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: Double

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: Early Erlotinib
Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Drug: Erlotinib
Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
Other Names:
  • Tarceva
Drug: Second-Line Chemotherapy
Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.
Placebo Comparator: Late Erlotinib
Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Drug: Erlotinib
Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
Other Names:
  • Tarceva
Drug: Placebo
Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.

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
Percentage of Participants Who Died During the Overall Study
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
Overall Survival (OS) as Median Time to Event During the Overall Study
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study
Time Frame: At 1 year
Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.
At 1 year

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
Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment
Time Frame: At 6 months
Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.
At 6 months
Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment
Time Frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)

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.
Hoffmann-La Roche

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

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.
September 1, 2011

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.
December 1, 2015

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.
January 1, 2016

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).
April 4, 2011

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.
April 4, 2011

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.
April 5, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
October 28, 2016

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.
September 6, 2016

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.
June 1, 2016

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.
  • BO25460

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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