NSCLCPhase 2NCT03394118
TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy
A Phase 2 study testing Osimertinib in people with NSCLC, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC
- 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
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2017to 8 Apr 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20, and patients who understand information about the trial and voluntarily agree to participate in the trial
- Histological or cytological confirmation diagnosis of NSCLC and inoperable stage IIIB or IV at the time of study enrolment
- Patients with EGFR sensitizing mutation (E19Del, L858R, L861Q, G719X) positive, who had shown clinical benefits (responders (CR or PR) and SD ≥6 months) from EGFR-TKIs and had developed progressive disease following those therapy
- Patients who have histories of previous exposure to EGFR-TKIs or other systemic chemotherapies are permitted (regardless of the order of treatment)
- Treated with at least one of KGFR-TKIs (regardless of treatment with or without systemic chemotherapies)
- In case the patient previously received any of the treatments including systemic chemotherapy, radiation therapy, surgery, and hormonal therapy, there should be at least 2 weeks of time interval between the last day of the previous treatment and the start of TAGRISSO™, and the remaining toxicity should be ≤ CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2, prior platinum-therapy related neuropathy)
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- ECOG performance status 0-2
- Patients in whom T790 mutations are detected in at least one of the samples including tumor tissues, BALF (cell-free DNA), plasma (cell-free DNA), and pleural effusion (cell-free DNA)
- At least one measurable lesions according to RECIST v 1.1
- Female with childbearing potential (within 1 year of time interval between last menses and the date of informed consent) who use appropriate contraception methods and are not on breast-feeding, and tested negative for pregnancy test or are sure to have a proof for infertility prior to drug initiation
- Males willing to use barrier contraception methods during study period (Patients should inform their sexual partners of the use of the allowed contraception methods.)
- Patients willing to provide informed consent with date and signature included prior to all study-specific procedures, samplings and analyse
- Patients who have proper organ functions as follows:
- ANC ≥ 1500/mm3,
- PLT counts ≥ 100,000/mm3,
- Hb ≥ 9.0g/dL,
- Serum creatinine ≤ upper normal limit,
- AST/ ALT/ ALP ≤ 3 times upper normal limit, Total bilirubin ≤2.0mg/dL (In case of liver metastasis AST/ ALT/ ALP ≤ 5 times upper normal limit, in case of bone metastasis, ALP ≤ 5 times upper normal limit)
- Patients must have a life expectancy ≥ 12 weeks
Who cannot join
- Patients who were previously treated with any of the drugs targeting T790M mutation such as AZD9291 (Osimertinib), HM61713 (Olmutinib), and CO-1686 (Rociletinib)
- Patients currently receiving medications known to be potent inhibitors of CYP3A4 and potent inducers of CYP3A4 (at least 1week prior study enrolment)
- Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, CIS cervical cancer, DCIS breast cancer, thyroid cancer or malignancies that were effectively treated, have maintained at least 3 years of remission state and can be regarded as completely cured
- Patients who have severe or unstable medical conditions such as prior or current clinically significant cardiovascular abnormality in accordance with the investigator's judgment such as uncontrolled hypertension, heart failure (NYHA classification ≥3), unstable angina or uncontrolled arrhythmia, and acute myocardial infarction within 6 months before study enrolment corrected QTcB >450msec in 12 lead EKG
- Patients with current or prior interstitial lung disease
- Patients with current or prior uncontrolled gastrointestinal diseases (e.g., crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption) that would preclude adequate absorption of IP.
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- Patients with active hepatitis B (identified by the presence of HBsAg and/or HBV DNA), active hepatitis C (identified by the presence of HCV RNA), and known human immunodeficiency virus (HIV)
- Patients with histories of hypersensitivity to IP or any components of the agent
- Patients with any of the following genetic predispositions including galactose intolerance, lactose intolerance, or glucose-galactose malabsorption
- Patients with symptomatic CNS metastases who are neurologically unstable (Cases with radiologically and neurologically stable disease after discontinuation of the administration of corticosteroids and anticonvulsants for at least 4 weeks are excluded)
- Patients with uncontrolled infective diseases (Patients who require non-oral antibiotics injection must be excluded, but they can be included if the diseases are completely resolved.)
- Patients who are difficult or unlikely to comply with study procedures, restrictions, requirements, and follow-up managements according to the investigator's judgment
- Patients who were administered other study drugs within 30 days before starting the study treatment (Patients are permitted if they were given any of the drugs including gefitinib, erlotinib, and afatinib)
- Patients with 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.
- 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 (urine or serum) pregnancy test prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study for Evaluating Anti-tumor Efficacy of TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy Using Bronchoalveolar Lavage Fluid, Plasma or Pleural Effusion
In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy.
Read the detailed description
This study is designed to be a phase II, Open-label, single-arm, single-center study to evaluate anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy using at least one of the samples such as plasma, bronchoalveolar lavage fluid, and pleural effusion. Approximately 63 patients will be enrolled into the trial, and expected study duration is 43 months from IRB and Korea: MFDA approval date.
Each subject will continue the study drug (Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily.
A cycle of study treatment is defined as 28 days. Patients will be enrolled for 31 months and will be followed-up regularly, and duration of follow-up for each patient will be 12 months.
- Conditions
- NSCLC
- Being tested
- Osimertinib
- Keywords
- T790 mutation, Liquid biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
A cycle of study treatment is defined as 28 days. Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Group_TAGRISSO | Experimental | Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) including rate of CR and PR on based of RECIST 1.1
Measured: through study completion (43 months)
Secondary outcomes (8)
DCR
Disease control rate (DCR) including rate of CR, PR and SD on based of RECIST 1.1
Measured: through study completion (43 months)
PFS
Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause.
Measured: through study completion (43 months)
T790M postive rate in Plasma cell free DNA
Measured: through study completion (43 months)
T790M postive rate in BALF free DNA
Measured: through study completion (43 months)
T790M postive rate in tissue
Measured: through study completion (43 months)
Concordance rate of T790M positivity between plasma & BALF
Measured: through study completion (43 months)
T790M sensitivity & specificity in Plasma & BALF (gold standard: tissue biopsy)
Measured: through study completion (43 months)
The frequency of occurrence of grade 3 or higher AE/SAEs
AE/SAE assessement on the base of NCI-CTCAE (version 4.03).
Measured: through study completion (43 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start11 Aug 2017
- Primary completion11 Mar 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Chang-Min Choi, Asan Medical Center
- Investigators
- Chang-Min Cho, Ph. D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394118
- Sponsor's protocol ID
- C2016-00578_ESR-16-11898
- Status last verified
- Apr 2021
- First submitted
- 1 Aug 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study for Evaluating Anti-tumor Efficacy of TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy Using Bronchoalveolar Lavage Fluid, Plasma or Pleural Effusion
- ClinicalTrials.gov ID
- NCT03394118
- Acronym / sponsor ID
- C2016-00578_ESR-16-11898
- Conditions
- NSCLC
- Keywords
- T790 mutation, Liquid biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 9 Jan 2018 (actual)
- 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.
In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy.
Detailed description
This study is designed to be a phase II, Open-label, single-arm, single-center study to evaluate anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy using at least one of the samples such as plasma, bronchoalveolar lavage fluid, and pleural effusion. Approximately 63 patients will be enrolled into the trial, and expected study duration is 43 months from IRB and Korea: MFDA approval date.
Each subject will continue the study drug (Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily.
A cycle of study treatment is defined as 28 days. Patients will be enrolled for 31 months and will be followed-up regularly, and duration of follow-up for each patient will be 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group_TAGRISSO | Experimental | Drug: OsimertinibEach subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 20, and patients who understand information about the trial and voluntarily agree to participate in the trial
- Histological or cytological confirmation diagnosis of NSCLC and inoperable stage IIIB or IV at the time of study enrolment
- Patients with EGFR sensitizing mutation (E19Del, L858R, L861Q, G719X) positive, who had shown clinical benefits (responders (CR or PR) and SD ≥6 months) from EGFR-TKIs and had developed progressive disease following those therapy
- ECOG performance status 0-2
- Patients in whom T790 mutations are detected in at least one of the samples including tumor tissues, BALF (cell-free DNA), plasma (cell-free DNA), and pleural effusion (cell-free DNA)
Key exclusion criteria (15 listed)
- Patients who were previously treated with any of the drugs targeting T790M mutation such as AZD9291 (Osimertinib), HM61713 (Olmutinib), and CO-1686 (Rociletinib)
- Patients currently receiving medications known to be potent inhibitors of CYP3A4 and potent inducers of CYP3A4 (at least 1week prior study enrolment)
- Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, CIS cervical cancer, DCIS breast cancer, thyroid cancer or malignancies that were effectively treated, have maintained at least 3 years of remission state and can be regarded as completely cured
- Patients who have severe or unstable medical conditions such as prior or current clinically significant cardiovascular abnormality in accordance with the investigator's judgment such as uncontrolled hypertension, heart failure (NYHA classification ≥3), unstable angina or uncontrolled arrhythmia, and acute myocardial infarction within 6 months before study enrolment corrected QTcB >450msec in 12 lead EKG
- Patients with current or prior interstitial lung disease
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 |
|---|---|---|
| OsimertinibA cycle of study treatment is defined as 28 days. Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily. | Drug | Group_TAGRISSO |
Primary outcome
ORR
Time frame: through study completion (43 months)
Objective response rate (ORR) including rate of CR and PR on based of RECIST 1.1
8 secondary outcomes
DCR
Time frame: through study completion (43 months)
PFS
Time frame: through study completion (43 months)
T790M postive rate in Plasma cell free DNA
Time frame: through study completion (43 months)
T790M postive rate in BALF free DNA
Time frame: through study completion (43 months)
T790M postive rate in tissue
Time frame: through study completion (43 months)
Concordance rate of T790M positivity between plasma & BALF
Time frame: through study completion (43 months)
T790M sensitivity & specificity in Plasma & BALF (gold standard: tissue biopsy)
Time frame: through study completion (43 months)
The frequency of occurrence of grade 3 or higher AE/SAEs
Time frame: through study completion (43 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- 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.
Chang-Min Cho, Ph. D principal investigator
Asan Medical Center
1 site in 1 country: 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 NSCLC, run by Asan Medical Center at 1 site in South Korea.
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 19 inclusion and 15 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ORR (time frame: through study completion (43 months)). 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 27 Apr 2021.