A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib (ELIOS)

October 2, 2024 updated by: AstraZeneca

A Multicentre, Open-label, Single-arm, Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.

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

Study design This is a phase II, open-label, single-arm tissue and plasma acquisition study assessing the efficacy, safety and underlying resistance mechanisms of osimertinib (80 mg orally, once daily) as first-line treatment in patients with locally advanced or metastatic EGFR mutation positive non-small cell lung cancer who are EGFR tyrosine kinase inhibitor treatment-naïve and eligible for first-line treatment. Participants with EGFR mutation-positive non-small cell lung cancer will be required to consent to 2 mandatory tumour biopsies to be considered for enrolment in this study. The first biopsy will be done prior to initiating treatment with osimertinib and the second biopsy will be obtained any time between Investigator assessed, Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)-defined progression and before the start of any new anticancer treatment. A third optional biopsy may be taken during the course of treatment at the Investigator's discretion if the patient consents and if clinically feasible. Tumour tissue and plasma samples will be collected and examined for genetic and non genetic aberrations that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care. Patients should continue on osimertinib until progression or until other treatment discontinuation criteria are met. However, if patients continue to show clinical benefit to treatment as judged by the Investigator, patients may continue to receive osimertinib beyond RECIST 1.1-defined progression. Therefore, there is no maximum duration of treatment. Tumour assessments will be performed at baseline and then every 8 weeks from study enrolment until 3.5 years, and then every 10 weeks until RECIST 1.1-defined. Patients will be followed up for a period of 28 days following discontinuation of osimertinib. Target patient population Male and female patients aged 18 years and over with locally advanced or metastatic pathologically confirmed adenocarcinoma of the lung, not amenable to curative surgery or radiotherapy. Patients will have a tumour that harbours one of the EGFR mutations known to be associated with EGFR tyrosine kinase inhibitor sensitivity, either alone or in combination with other EGFR mutations (EGFR mutation status determined by a local laboratory). Patients must be EGFR tyrosine kinase inhibitor treatment-naïve and eligible to receive first line treatment with osimertinib. Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR. Osimertinib (80 mg orally, once daily) will be administered. Doses may be reduced to 40 mg if needed.

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.
154

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 2

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

  • Italy
      • Brescia, Italy, 25100
        • Research Site
      • Meldola, Italy, 47014
        • Research Site
      • Monza, Italy, 20900
        • Research Site
      • Parma, Italy, 43126
        • Research Site
      • Roma, Italy, 00152
        • Research Site
      • Terni, Italy, 05100
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Research Site
      • Cheongiu, Korea, Republic of, 28644
        • Research Site
      • Seongnam, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
  • Malaysia
      • Johor Bahru, Malaysia, 81100
        • Research Site
      • Kuantan, Malaysia, 25100
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
      • Lembah Pantai, Malaysia, 59100
        • Research Site
      • Pulau Pinang, Malaysia, 10450
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Las Palmas de Gran Canaria, Spain, 35016
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Sevilla, Spain, 41009
        • Research Site
  • United States
    • Georgia
      • Athens, Georgia, United States, 30607
        • Research Site
      • Atlanta, Georgia, United States, 30307
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • 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:

  1. Provision of informed consent prior
  2. Patients aged 18 years or older
  3. Patients with histological confirmation of locally advanced or metastatic NSCLC
  4. Patients with M1 stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
  5. Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity
  6. Existence of measurable or evaluable disease (as per RECIST 1.1 criteria).
  7. Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
  8. WHO performance status 0-1
  9. Life expectancy ≥12 weeks
  10. Capacity to swallow
  11. Patients able to complete study and within geographical proximity allowing for adequate follow up
  12. Resolution of all acute toxic effects of previous anticancer therapy
  13. Female patients must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential
  14. Male patients must be willing to use barrier contraception

Exclusion Criteria:

  1. Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy
  2. Patients diagnosed with another lung cancer subtype
  3. Patients with an EGFR exon 20 insertion
  4. Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
  5. Second active neoplasia
  6. Treatment with an investigational drug within five half-lives of the compound
  7. Participation in another clinical study with an investigational product (IP) during the last 3 weeks before the first day of study treatment
  8. Patients who have received prior immunotherapies
  9. Patients who have received prior EGFR treatments for lung cancer
  10. Patients who have received prior treatment with an EGFR TKI including in the adjuvant setting
  11. Patients who have received previous treatment for metastatic or stage IV disease
  12. Prior treatment with cytotoxic chemotherapy for advanced NSCLC
  13. Patients with a history of cancer that has been completely treated, with no evidence of malignant disease currently cannot be enrolled in the study if their chemotherapy was completed less than 6 months prior and/or have received a bone marrow transplant less than 2 years before the first day of study treatment
  14. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
  15. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection (eg, patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled Hepatitis B virus (HBV) infection.
  16. Patients who have had a surgical procedure unrelated to the study within 14 days or major surgery within 1 month prior to the administration of the study drug
  17. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis
  18. Any of the following cardiac criteria: Mean resting QT interval corrected for heart rate (QTc) more than 470 msec, obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, hypomagnesaemia, hypocalcaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
  19. Spinal cord compression, symptomatic and unstable brain metastases except for those patients who have completed definitive therapy, and have had a stable neurological status for at least 2 weeks after completion of definitive therapy. 20.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib

21.Inadequate bone marrow reserve or organ function 22.Female patients who are breastfeeding 23.Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome (CYP) 3A4.

24.Patient unwilling to undergo a biopsy at the time of disease progression 25.History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib 26.Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements 27.Involvement in the planning and/or conduct of the study 28.Previous enrolment in the present study

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: N/A
  • Interventional Model: Single Group 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
An oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer
Drug: Osimertinib
Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR.
Other Names:
  • TAGRISSO, AZD9291

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
Proportion of Patients With a Given Tumour Genetic and Proteomic Marker at the Point of Disease Progression
Time Frame: Genetic and proteomic markers were assessed at baseline and progression (up to 5 years after baseline)
The frequency of genetic and proteomic markers at disease progression regardless of their prevalence was evaluated.
Genetic and proteomic markers were assessed at baseline and progression (up to 5 years after baseline)

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 (PFS)
Time Frame: From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years
PFS is defined as the time from first dose of osimertinib until the date of Investigator assessed Response Evaluation Criteria in Solid Tumours (RECIST) 1.1-defined progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to progression.
From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years
Objective Response Rate (ORR)
Time Frame: From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
ORR is defined as the number (%) of patients with at least one visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
Duration of Response (DoR)
Time Frame: From date of first documentation of complete/partial response until the date of progression, or last evaluable RECIST assessment for participants that did not progress within 2 missed visits of last assessment, up to 5 years
Duration of response is defined as the time from the date of first documented response, (that is subsequently confirmed) until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit that was CR or PR that was subsequently confirmed.
From date of first documentation of complete/partial response until the date of progression, or last evaluable RECIST assessment for participants that did not progress within 2 missed visits of last assessment, up to 5 years
Disease Control Rate (DCR)
Time Frame: 8 weeks
DCR is defined as percentage of patients with confirmed complete response, confirmed partial response or with stable disease.
8 weeks
Time to Treatment Discontinuation or Death (TTD)
Time Frame: From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years
TTD is defined as the time from the date of first dose of osimertinib to the earliest of treatment discontinuation or death.
From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years
Time to First Subsequent Therapy or Death (TFST)
Time Frame: From date of first dose to start of subsequent anticancer therapy or death (by any cause in the absence of recurrence), up to 5 years
TFST is defined as the time from the date of first dose of osimertinib to the earlier of the date of anticancer therapy start date following study treatment discontinuation, or death.
From date of first dose to start of subsequent anticancer therapy or death (by any cause in the absence of recurrence), up to 5 years
PFS in Patient Subgroups Defined by Molecular Profile: Epidermal Growth Factor Receptor (EGFR) Tumor Mutation at Baseline
Time Frame: From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years
PFS is defined as the time from first dose of osimertinib until the date of Investigator assessed Response Evaluation Criteria in Solid Tumours (RECIST) 1.1-defined progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to progression. PFS was analysed in patient subgroups defined by molecular profile, including but not limited to: EGFR tumor mutation at baseline-Exon19del or L858R
From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years
PFS in Patient Subgroups Defined by Molecular Profile: Detectable in Plasma-Derived ctDNA at Baseline
Time Frame: From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years
PFS is defined as the time from first dose of osimertinib until the date of Investigator assessed Response Evaluation Criteria in Solid Tumours (RECIST) 1.1-defined progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to progression. PFS was analysed in patient subgroups defined by molecular profile, including but not limited to: Exon19del or L858R detectable in plasma derived circulating tumour deoxyribonucleic acid (ctDNA) at baseline.
From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years
ORR in Patient Subgroups Defined by Molecular Profile: EGFR Tumor Mutation at Baseline
Time Frame: From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
ORR is defined as the number (%) of patients with at least one visit response of complete response or partial response that is confirmed at least 4 weeks later. ORR was analysed in patient subgroups defined by molecular profile: EGFR tumor mutation at baseline-Exon19del or L858R
From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
ORR in Patient Subgroups Defined by Molecular Profile: Detectable in Plasma Derived ctDNA at Baseline
Time Frame: From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
ORR is defined as the number (%) of patients with at least one visit response of complete response or partial response that is confirmed at least 4 weeks later. ORR was analysed in patient subgroups defined by molecular profile: Exon19del or L858R detectable in plasma derived ctDNA at baseline.
From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
TTD in Patient Subgroups Defined by Molecular Profile: EGFR Tumor Mutation at Baseline
Time Frame: From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years
TTD is defined as the time from the date of first dose of osimertinib to the earliest of treatment discontinuation or death. TTD was analysed in patient subgroups defined by molecular profile: EGFR tumor mutation at baseline-Exon19del or L858R
From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years
TTD in Patient Subgroups Defined by Molecular Profile: Detectable in Plasma Derived ctDNA at Baseline
Time Frame: From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years
TTD is defined as the time from the date of first dose of osimertinib to the earliest of treatment discontinuation or death. TTD was analysed in patient subgroups defined by molecular profile: Exon19del or L858R detectable in plasma derived ctDNA at baseline.
From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years
Tumour Shrinkage/Depth of Response in Patient Subgroups Defined by Molecular Profile: EGFR Tumor Mutation at Baseline
Time Frame: From date of first dose until last recorded post baseline RECIST target lesion assessment scan, up to 5 years
Tumour shrinkage is defined as the best change from baseline in the sum of diameters of target lesions, in patient subgroups defined by molecular profile: EGFR tumor mutation at baseline-Exon19del or L858R. A negative change denotes a reduction in target lesion size.
From date of first dose until last recorded post baseline RECIST target lesion assessment scan, up to 5 years
Tumour Shrinkage/Depth of Response in Patient Subgroups Defined by Molecular Profile: Detectable in Plasma Derived ctDNA at Baseline
Time Frame: From date of first dose until last recorded post baseline RECIST target lesion assessment scan, up to 5 years
Tumour shrinkage is defined as the best change from baseline in the sum of diameters of target lesions, in patient subgroups defined by molecular profile: Exon19del or L858R detectable in plasma derived ctDNA at baseline. A negative change denotes a reduction in target lesion size.
From date of first dose until last recorded post baseline RECIST target lesion assessment scan, up to 5 years

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
Adverse events graded by Common Terminology Criteria for Adverse Events version 4.0
Time Frame: At every visit from signing informed consent until 28 days after last dose of study treatment
To summarize the safety and tolerability profile of osimertinib as first-line EGFR tyrosine kinase inhibitor therapy for patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer
At every visit from signing informed consent until 28 days after last dose of study treatment

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

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.
Parexel

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: Zosia Piotrowska, MD, Massachusetts General Hospital

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.

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.
May 30, 2018

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.
September 19, 2023

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.
September 19, 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).
July 27, 2017

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.
August 1, 2017

First Posted (Actual)

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.
August 4, 2017

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.
October 21, 2024

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.
October 2, 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.
September 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.
  • D5161C00003
  • 2017-002359-27 (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

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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