AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (AURA3)

December 12, 2024 updated by: AstraZeneca

A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3).

A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

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.

Detailed Description

This is a phase III, open label, randomized study assessing Osimertinib (80 mg, orally, once daily) versus platinum-based doublet chemotherapy (standard of care) in subjects with confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) mutation positive NSCLC, who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent and whose tumours harbour a T790M mutation within the EGFR Gene. Subjects must be chemotherapy naive and must agree to provide a biopsy for central confirmation of T790 mutation status following confirmed disease progression on their first line EGFR-TKI treatment (e.g. erlotinib, gefitinib or afatinib). Suitable subjects will then be randomized to receive either Osimertinib (80mg orally, once daily) or platinum-based doublet chemotherapy (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve AUC 5 or pemetrexed 500 mg/m2 + cisplatin 75 mg/m2) on Day 1 of every 21-day cycle in a 2:1 (Osimertinib: platinum-based doublet chemotherapy) ratio. Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review, they will be given the opportunity to begin treatment with Osimertinib 80mg, once daily. These subjects may continue treatment with Osimertinib even after disease progression, as long as they are continuing to show clinical benefit, as judged by the investigator. The primary objective of the study is to assess the efficacy of Osimertinib compared with platinum-based doublet chemotherapy by assessment of Progression Free Survival (PFS), using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1), as well as asensitivity analysis of Progression Free Survival using Blinded Independent Central Review (BICR).

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.
421

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

  • Australia
      • Darlinghurst, Australia, 2010
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • Kogarah, Australia, 2217
        • Research Site
      • Nedlands, Australia, 6009
        • Research Site
      • Woolloongabba, Australia, 4102
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Research Site
  • China
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100021
        • Research Site
      • Changchun, China, 130000
        • Research Site
      • Chongqing, China, 400038
        • Research Site
      • Chongqing, China, 400042
        • Research Site
      • Fuzhou, China, 350014
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Guangzhou, China, 510100
        • Research Site
      • Hangzhou, China, 310003
        • Research Site
      • Harbin, China, 150049
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Shanghai, China, 200030
        • Research Site
      • Shanghai, China, CN-200433
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
      • Ürümqi, China, 830000
        • Research Site
  • France
      • Clermont Ferrand, France, 63003
        • Research Site
      • Dijon, France, 21079
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Marseille Cedex 20, France, 13915
        • Research Site
      • Paris, France, 75020
        • Research Site
      • Strasbourg Cedex, France, 67091
        • Research Site
      • Toulouse Cedex 09, France, 31059
        • Research Site
      • Villejuif, France, 94800
        • Research Site
  • Germany
      • Essen, Germany, 45122
        • Research Site
      • Frankfurt, Germany, 60590
        • Research Site
      • Gerlingen, Germany, 70839
        • Research Site
      • Oldenburg, Germany, 26121
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Shatin, Hong Kong, 00000
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
  • Italy
      • Avellino, Italy, 83100
        • Research Site
      • Meldola, Italy, 47014
        • Research Site
      • Milano, Italy, 20133
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
      • Roma, Italy, 00128
        • Research Site
  • Japan
      • Akashi-shi, Japan, 673-8558
        • Research Site
      • Bunkyo-ku, Japan, 113-8431
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Hirakata-shi, Japan, 573-1191
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Research Site
      • Kobe-shi, Japan, 650-0047
        • Research Site
      • Kurashiki-shi, Japan, 710-8602
        • Research Site
      • Kyoto-shi, Japan, 606-8507
        • Research Site
      • Matsuyama-shi, Japan, 791-0280
        • Research Site
      • Nagoya-shi, Japan, 464-8681
        • Research Site
      • Natori-shi, Japan, 981-1293
        • Research Site
      • Niigata-shi, Japan, 951-8566
        • Research Site
      • Okayama-shi, Japan, 700-8558
        • Research Site
      • Osaka-shi, Japan, 541-8567
        • Research Site
      • Osaka-shi, Japan, 534-0021
        • Research Site
      • Osakasayama, Japan, 589-8511
        • Research Site
      • Sakai-shi, Japan, 591-8555
        • Research Site
      • Shinjuku-ku, Japan, 160-0023
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Takatsuki-shi, Japan, 569-8686
        • Research Site
      • Wakayama-shi, Japan, 641-8510
        • Research Site
      • Yokohama-shi, Japan, 241-8515
        • Research Site
      • Yokohama-shi, Japan, 236-0024
        • Research Site
      • Yokohama-shi, Japan, 236-0051
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Research Site
      • Cheongju-si, Korea, Republic of, 28644
        • Research Site
      • Goyang-si, Korea, Republic of, 10408
        • Research Site
      • Incheon, Korea, Republic of, 21565
        • Research Site
      • Jinju-si, Korea, Republic of, 660-702
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 156-707
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
      • Seoul, Korea, Republic of, 6351
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
      • Ulsan, Korea, Republic of, 44033
        • Research Site
  • Mexico
      • Mexico, Mexico, 52763
        • Research Site
      • Oaxaca, Mexico, 68000
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Groningen, Netherlands, 9713 GZ
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620905
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Omsk, Russian Federation, 644013
        • Research Site
      • Saint Petersburg, Russian Federation, 197342
        • Research Site
      • Saint Petersburg,, Russian Federation, 197758
        • Research Site
      • Saint-Petersburg, Russian Federation, 197183
        • Research Site
  • Spain
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 08035
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Sevilla, Spain, 41013
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Lund, Sweden, 221 85
        • Research Site
      • Stockholm, Sweden, 171 76
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Research Site
      • Hsinchu, Taiwan, 300
        • Research Site
      • Kaohsiung, Taiwan, 82445
        • Research Site
      • Kaohsiung, Taiwan, 81362
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB2 2ZB
        • Research Site
      • Bristol, United Kingdom, BS2 8ED
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Glasgow, United Kingdom, G12 0YN
        • Research Site
      • Huddersfield, United Kingdom, HD3 3EA
        • Research Site
      • London, United Kingdom, W1G 6AD
        • Research Site
      • London, United Kingdom, SW10 9NH
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Newcastle-Upon-Tyne, United Kingdom, NE7 7DN
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Research Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Research Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Research Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Washington
      • Lacey, Washington, United States, 98503
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site

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 to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with histologically or cytologically documented NSCLC.
  • Locally advanced or metastatic NSCLC
  • Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
  • Eligible to receive treatment with the selected doublet-chemotherapy
  • Central confirmation of T790M+ mutation status
  • World Health Organization (WHO) performance status 0-1
  • At least one lesion, not previously irradiated.

Exclusion Criteria:

  • • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
  • Treatment with more than one prior line of treatment for advanced NSCLC
  • Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
  • Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
  • Previous treatment with Osimertinib, or a 3rd generation EGFR TKI

For subjects who cross-over to Osimertinib:

  • Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
  • At least 14 days since last dose of platinum-based doublet chemotherapy

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: Osimertinib
Osimertinib 80 mg, orally, once daily
Drug: Chemotherapy
Randomization to either Osimertinib or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (Osimertinib:platinum-based doublet-chemotherapy) ratio
Other Names:
  • Osimertinib
  • Platinum-based Doublet-Chemotherapy
Drug: Cross-over to Osimertinib

Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review, they will be given the opportunity to begin treatment with Osimertinib 80mg, once daily. These subjects may continue treatment with Osimertinib even after disease progression, as long as they are continuing to show clinical benefit, as judged by the investigator.

Subjects who stop platinum-based doublet chemotherapy for reasons other than objective disease progression according to RECIST 1.1 will not be eligible to cross-over to Osimertinib.
Active Comparator: Platinum-based doublet chemotherapy
pemetrexed 500mg/m2 + carboplatin AUC5 or pemetrexed 500mg/m2 + cisplatin 75mg/m2
Drug: Chemotherapy
Randomization to either Osimertinib or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (Osimertinib:platinum-based doublet-chemotherapy) ratio
Other Names:
  • Osimertinib
  • Platinum-based Doublet-Chemotherapy

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 (PFS) by Investigator Assessment
Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).

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
Objective Response Rate (ORR) by Investigator Assessment
Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Duration of Response (DoR) by Investigator Assessment
Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Disease Control Rate (DCR) by Investigator Assessment
Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD at >=6 weeks, prior to any progressive disease (PD).
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Tumour Shrinkage by Investigator Assessment
Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Secondary: Overall Survival (OS)
Time Frame: From date of randomization until time of final OS analysis, a median follow-up of 43 months
From date of randomization until time of final OS analysis, a median follow-up of 43 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Subsequent Therapy (TFST)
Time Frame: From date of randomisation until time of final OS analysis, a median follow-up of 43 months
Time from randomisation to first subsequent anti-cancer therapy (FST) following randomised treatment discontinuation, or death if no FST administered. Any patient not known to have died nor received any subsequent anti-cancer therapy (ST) was censored at the last time known not to have received ST, ie, the last follow-up visit this was confirmed.
From date of randomisation until time of final OS analysis, a median follow-up of 43 months
Time to Second Subsequent Therapy (TSST)
Time Frame: From date of randomisation until time of final OS analysis, a median follow-up of 43 months
Time from randomisation to second subsequent anti-cancer therapy (SST) following randomised treatment discontinuation, or death if no SST administered. Any patient not known to have died nor received any SST was censored at the last time known not to have received SST, ie, the last follow-up visit this was confirmed.
From date of randomisation until time of final OS analysis, a median follow-up of 43 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.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yilong Wu, MD, Guangdong General Hospital, Guangdong, 510030, China
  • Principal Investigator: Vassiliki A Papadimitrakopoulou, MD, The University of Texas/M.D. Anderson Cancer Center, Houston, Tx, USA

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.
August 4, 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.
April 15, 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.
December 15, 2023

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).
May 15, 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.
May 30, 2014

First Posted (Estimated)

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.
June 2, 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 25, 2025

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.
December 12, 2024

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.
December 1, 2024

More Information

Terms related to this study

Keywords

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.
  • D5160C00003
  • 2014-000594-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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