Carcinoma, Non-Small-Cell LungPhase 2PLASMANCT02811354
Phase II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected in Plasma Ct-DNA
A Phase 2 study testing AZD9291 in people with Carcinoma, Non-Small-Cell Lung, run by National University Hospital, Singapore at 8 sites in 5 countries.
Trial summary
Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR sensitizing mutations and T790M detected in plasma ctDNA. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- AZD9291
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 24 Feb 2017to 24 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Patients must be >= 21 years of age.
- Locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy
- Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
- Radiological documentation of disease progression: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
- Patient may receive up to two lines of therapies (including EGFR TKI).
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- Plasma sample must harbour an EGFR mutation known to be associated with EGFR TKI sensitivity (exon 19 deletion, L858R). Confirmation of T790M status by central lab testing from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Haemoglobin >= 10.0 g/dL and no blood transfusions in the 28 days prior to entry
- Absolute neutrophil count (ANC) >= 1.5 x 109/L
- No features suggestive of MDS/AML on peripheral blood smear
- White blood cells (WBC) > 3x109/L
- Platelet count >= 100 x 109/L
- Total bilirubin <= 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) <= 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be <= 5x ULN
- Serum creatinine <= 1.5 x institutional upper limit of normal (ULN)
- ECOG performance status 0-2
- Patients must have a life expectancy >= 12 weeks.
- Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male patients should be willing to use barrier contraception (see Restrictions, Section 5.1)
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- At least one lesion, not previously irradiated, that can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes which must have short axis >= 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Treatment with an EGFR-TKI within 8 days of study entry; any cytotoxic chemotherapy, or other anticancer drugs within 21 days of study entry
- Treatment with an investigational drug within five half-lives of the compound
- Prior treatment with an immune checkpoint inhibitor
- Previous treatment with AZD9291 (or 3rd generation EGFR TKIs)
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >= 5 years
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- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks
- The patient may receive bisphosphonates for the treatment of bone metastases.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
- Unstable spinal cord compression/brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment.
- Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix A). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, 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
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9291
- History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents
- Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry
- 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
- Previous allogeneic bone marrow transplant.
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
South Korea3 sites, 3 recruiting
- Recruiting
Samsung Medical Center Sungkyunkwan University
Irwon-dong, Seoul
Keunchil Park, keunchil.park@samsung.com
- Recruiting
Yonsei Cancer Center
Sinchon-dong, Seoul
Byoung Chul Cho, cbc1971@yuhs.ac
- Recruiting
Seoul National University College of Medicine
Yeongeon-dong, Seoul, 03080
Dong Wan Kim, kimdw@snu.ac.kr
Hong Kong2 sites, 2 recruiting
- Recruiting
Pamela Youde Nethersole Eastern Hospital
Chai Wan
Rebecca Yeong, Dr, +852-2595 6111, yeungmwr@ha.org.hk
- Recruiting
Prince of Wales Hospital
Shatin
Tony Mak, Prof, (852) 3505-2166
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 164119
Ross Soo, (65) 6779 5555, ross_soo@nuhs.edu.sg
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Bin-Chi Liao, +886975582029, pierrotpterion@ntuh.gov.tw
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
Thanyanan Reungwetwattana, +6698-097-8810, thanyanan.reu@mahidol.ac.th
About this study
Official title: Phase II Study of AZD9291 in Patients With Advanced Stage Non-small Cell Lung Cancer Following Prior EGFR TKI Therapy With EGFR and T790M Mutations Detected in Plasma Circulating Tumor DNA (PLASMA)
Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR sensitizing mutations and T790M detected in plasma ctDNA.
This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 106 subjects will be enrolled.
All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study.
Read the detailed description
As T790M is the most common mechanism of acquired resistance to EGFR TKI, EGFR TKIs targeting T790M has been developed.
AZD9291 is an oral, potent, irreversible EGFR-TKI selective for sensitizing (EGFRm) and T790M resistance mutation with a significant selectivity margin against wild-type EGFR. As a result, AZD9291 can effectively block EGFR signaling both in EGFR single mutant cells with activating EGFR mutations and in double mutant cells bearing the resistance T790M mutation.
This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions and exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 108 subjects will be enrolled.
All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study.
Target patient population:
Patients will be > 18 years of age, with a diagnosis of locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy with documented activating EGFR mutations (exon 19 deletions and exon 21 L858R substitution mutations) at the time of initial diagnosis, have radiological disease progression following either 1st line EGFR TKI treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Plasma sample must harbour an EGFR mutation known to be associated with EGFR TKI sensitivity (exon 19 deletion, L858R as well as presence of T790M by central lab testing from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen. Patients must have normal organ and bone marrow function and ECOG PS 0-2.
Treatment and regimens:
Patient will be treated with AZD9291 at a starting dose of 80mg once a day until the patient completes the study, withdraws from the study or closure of the study. A cycle of treatment is defined as 28 days of once daily AZD9291 treatment. Patients may continue to receive AZD9291 until objective disease progression (determined by RECIST 1.1) or if the subject is no longer receiving clinical benefit in the Investigator's opinion.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- AZD9291
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9291Drug
Also called Osimertinib
oral administration as a single daily dose of 80 mg
| Study group | Role | What they receive |
|---|---|---|
| AZD9291 | Experimental | Patient will be treated with AZD9291 at a starting dose of 80mg once a day until the patient completes the study, withdraws from the study or closure of the study. A cycle of treatment is defined as 28 days of once daily AZD9291 treatment. Patients may continue to receive AZD9291 until objective disease progression (determined by RECIST 1.1) or if the subject is no longer receiving clinical benefit in the Investigator's opinion. Receives: Drug: AZD9291 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Secondary outcomes (5)
Progression free survival (PFS)
Measured: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Duration of response (DoR)
Measured: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Disease control rate (DCR)
Measured: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Tumour shrinkage
Measured: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Overall survival (OS)
Measured: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start24 Feb 2017
- Primary completion24 Feb 2019 (estimated)
- Study completion24 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Ross Soo, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811354
- Sponsor's protocol ID
- ESR-15-10932
- Other IDs
- 2015/01069, 2015
- Acronym
- PLASMA
- Status last verified
- Sep 2018
- First submitted
- 21 Jun 2016
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang T, Zhou C. Clinical activity of the mutant-selective EGFR inhibitor AZD9291 in patients with EGFR inhibitor-resistant non-small cell lung cancer. Transl Lung Cancer Res. 2014 Dec;3(6):370-2. doi: 10.3978/j.issn.2218-6751.2014.08.02.
PubMed 25806323Cross DA, Ashton SE, Ghiorghiu S, Eberlein C, Nebhan CA, Spitzler PJ, Orme JP, Finlay MR, Ward RA, Mellor MJ, Hughes G, Rahi A, Jacobs VN, Red Brewer M, Ichihara E, Sun J, Jin H, Ballard P, Al-Kadhimi K, Rowlinson R, Klinowska T, Richmond GH, Cantarini M, Kim DW, Ranson MR, Pao W. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014 Sep;4(9):1046-61. doi: 10.1158/2159-8290.CD-14-0337. Epub 2014 Jun 3.
PubMed 24893891
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of AZD9291 in Patients With Advanced Stage Non-small Cell Lung Cancer Following Prior EGFR TKI Therapy With EGFR and T790M Mutations Detected in Plasma Circulating Tumor DNA (PLASMA)
- ClinicalTrials.gov ID
- NCT02811354
- Acronym / sponsor ID
- PLASMA / ESR-15-10932
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- AstraZeneca, Singapore Clinical Research Institute
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 24 Feb 2019 (estimated)
- Study completion
- 24 Feb 2020 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR sensitizing mutations and T790M detected in plasma ctDNA.
This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 106 subjects will be enrolled.
All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study.
Detailed description
As T790M is the most common mechanism of acquired resistance to EGFR TKI, EGFR TKIs targeting T790M has been developed.
AZD9291 is an oral, potent, irreversible EGFR-TKI selective for sensitizing (EGFRm) and T790M resistance mutation with a significant selectivity margin against wild-type EGFR. As a result, AZD9291 can effectively block EGFR signaling both in EGFR single mutant cells with activating EGFR mutations and in double mutant cells bearing the resistance T790M mutation.
This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions and exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 108 subjects will be enrolled.
All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study.
Target patient population:
Patients will be > 18 years of age, with a diagnosis of locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy with documented activating EGFR mutations (exon 19 deletions and exon 21 L858R substitution mutations) at the time of initial diagnosis, have radiological disease progression following either 1st line EGFR TKI treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Plasma sample must harbour an EGFR mutation known to be associated with EGFR TKI sensitivity (exon 19 deletion, L858R as well as presence of T790M by central lab testing from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen. Patients must have normal organ and bone marrow function and ECOG PS 0-2.
Treatment and regimens:
Patient will be treated with AZD9291 at a starting dose of 80mg once a day until the patient completes the study, withdraws from the study or closure of the study. A cycle of treatment is defined as 28 days of once daily AZD9291 treatment. Patients may continue to receive AZD9291 until objective disease progression (determined by RECIST 1.1) or if the subject is no longer receiving clinical benefit in the Investigator's opinion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD9291 | Experimental | Drug: AZD9291Patient will be treated with AZD9291 at a starting dose of 80mg once a day until the patient completes the study, withdraws from the study or closure of the study. A cycle of treatment is defined as 28 days of once daily AZD9291 treatment. Patients may continue to receive AZD9291 until objective disease progression (determined by RECIST 1.1) or if the subject is no longer receiving clinical benefit in the Investigator's opinion. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Provision of informed consent prior to any study specific procedures
- Patients must be >= 21 years of age.
- Locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy
- Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
- Radiological documentation of disease progression: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
Key exclusion criteria (24 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Treatment with an EGFR-TKI within 8 days of study entry; any cytotoxic chemotherapy, or other anticancer drugs within 21 days of study entry
- Treatment with an investigational drug within five half-lives of the compound
- Prior treatment with an immune checkpoint inhibitor
- Previous treatment with AZD9291 (or 3rd generation EGFR TKIs)
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 |
|---|---|---|
| AZD9291Also: Osimertiniboral administration as a single daily dose of 80 mg | Drug | AZD9291 |
Primary outcome
Objective response rate (ORR)
Time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
5 secondary outcomes
Progression free survival (PFS)
Time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Duration of response (DoR)
Time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Disease control rate (DCR)
Time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Tumour shrinkage
Time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Overall survival (OS)
Time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Background: PubMed 25806323Jiang T, Zhou C. Clinical activity of the mutant-selective EGFR inhibitor AZD9291 in patients with EGFR inhibitor-resistant non-small cell lung cancer. Transl Lung Cancer Res. 2014 Dec;3(6):370-2. doi: 10.3978/j.issn.2218-6751.2014.08.02.
- Background: PubMed 24893891Cross DA, Ashton SE, Ghiorghiu S, Eberlein C, Nebhan CA, Spitzler PJ, Orme JP, Finlay MR, Ward RA, Mellor MJ, Hughes G, Rahi A, Jacobs VN, Red Brewer M, Ichihara E, Sun J, Jin H, Ballard P, Al-Kadhimi K, Rowlinson R, Klinowska T, Richmond GH, Cantarini M, Kim DW, Ranson MR, Pao W. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014 Sep;4(9):1046-61. doi: 10.1158/2159-8290.CD-14-0337. Epub 2014 Jun 3.
- Individual participant dataSharing planned: Undecided
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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.
Ross Soo principal investigator
National University Hospital, Singapore
8 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 AZD9291 in people with Carcinoma, Non-Small-Cell Lung, run by National University Hospital, Singapore at 8 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 25 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, Hong Kong, Singapore, Taiwan, Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ross Soo ((65) 6779 5555, ross_soo@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From the time of their first treatment with daily AZD9291 till 28 days after discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811354, which also lists 2 linked publications.
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 20 Sep 2018.