EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 2ELIOSNCT03239340
A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
A Phase 2 study testing Osimertinib in people with EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by AstraZeneca at 26 sites in 5 countries.
Trial summary
A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 30 May 2018to 19 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior
- Patients aged 18 years or older
- Patients with histological confirmation of locally advanced or metastatic NSCLC
- Patients with M1 stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
- Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity
- Existence of measurable or evaluable disease (as per RECIST 1.1 criteria).
Show all 14Show fewer
- Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
- WHO performance status 0-1
- Life expectancy ≥12 weeks
- Capacity to swallow
- Patients able to complete study and within geographical proximity allowing for adequate follow up
- Resolution of all acute toxic effects of previous anticancer therapy
- 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
- Male patients must be willing to use barrier contraception
Who cannot join
- Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy
- Patients diagnosed with another lung cancer subtype
- Patients with an EGFR exon 20 insertion
- Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
- Second active neoplasia
- Treatment with an investigational drug within five half-lives of the compound
Show all 21Show fewer
- Participation in another clinical study with an investigational product (IP) during the last 3 weeks before the first day of study treatment
- Patients who have received prior immunotherapies
- Patients who have received prior EGFR treatments for lung cancer
- Patients who have received prior treatment with an EGFR TKI including in the adjuvant setting
- Patients who have received previous treatment for metastatic or stage IV disease
- Prior treatment with cytotoxic chemotherapy for advanced NSCLC
- 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
- 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
- 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.
- 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
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis
- 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
- 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
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
South Korea7 sites
Research Site
Busan, 47392
Research Site
Cheongiu, 28644
Research Site
Seongnam, 13620
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06591
Research Site
Seoul, 135-710
Italy6 sites
Research Site
Brescia, 25100
Research Site
Meldola, 47014
Research Site
Monza, 20900
Research Site
Parma, 43126
Research Site
Roma, 00152
Research Site
Terni, 05100
Malaysia5 sites
Research Site
Johor Bahru, 81100
Research Site
Kuantan, 25100
Research Site
Kuching, 93586
Research Site
Lembah Pantai, 59100
Research Site
Pulau Pinang, 10450
Spain5 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 08035
Research Site
Las Palmas de Gran Canaria, 35016
Research Site
Madrid, 28046
Research Site
Seville, 41009
United States3 sites
Research Site
Athens, Georgia, 30607
Research Site
Atlanta, Georgia, 30307
Research Site
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Being tested
- Osimertinib
- Keywords
- EGFR, NSCLC, Lung Cancer, Biopsy, Molecular Profiling
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called TAGRISSO, AZD9291
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.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | An oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With a Given Tumour Genetic and Proteomic Marker at the Point of Disease Progression
The frequency of genetic and proteomic markers at disease progression regardless of their prevalence was evaluated.
Measured: Genetic and proteomic markers were assessed at baseline and progression (up to 5 years after baseline)
Secondary outcomes (14)
Progression Free Survival (PFS)
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.
Measured: 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)
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.
Measured: From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years
Duration of Response (DoR)
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.
Measured: 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)
DCR is defined as percentage of patients with confirmed complete response, confirmed partial response or with stable disease.
Measured: 8 weeks
Time to Treatment Discontinuation or Death (TTD)
TTD is defined as the time from the date of first dose of osimertinib to the earliest of treatment discontinuation or death.
Measured: 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)
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From date of first dose until last recorded post baseline RECIST target lesion assessment scan, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start30 May 2018
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Zosia Piotrowska, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239340
- Sponsor's protocol ID
- D5161C00003
- Other IDs
- 2017-002359-27, 2017
- Acronym
- ELIOS
- Status last verified
- Sep 2024
- First submitted
- 27 Jul 2017
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Single-arm, Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
- ClinicalTrials.gov ID
- NCT03239340
- Acronym / sponsor ID
- ELIOS / D5161C00003
- Keywords
- EGFR, NSCLC, Lung Cancer, Biopsy, Molecular Profiling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 May 2018 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: OsimertinibAn oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of informed consent prior
- Patients aged 18 years or older
- Patients with histological confirmation of locally advanced or metastatic NSCLC
- Patients with M1 stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
- Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity
Key exclusion criteria (21 listed)
- Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy
- Patients diagnosed with another lung cancer subtype
- Patients with an EGFR exon 20 insertion
- Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
- Second active neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: TAGRISSO, AZD9291Osimertinib 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. | Drug | Osimertinib |
Primary outcome
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.
14 secondary outcomes
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
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
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
Disease Control Rate (DCR)
Time frame: 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
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
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 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
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 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
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 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
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/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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSR synopsisLink provided by the sponsor.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zosia Piotrowska, MD principal investigator
Massachusetts General Hospital
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib in people with EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by AstraZeneca at 26 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea, Italy, Malaysia, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.