Locally Advanced or Metastatic NSCLCPhase 2NCT03414814
Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation
A Phase 2 study testing Osimertinib 80 MG [Tagrisso] in people with Locally Advanced or Metastatic NSCLC, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- What is being tested?
- Osimertinib 80 MG [Tagrisso]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2018to 3 Aug 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Male or female must be > 19 years of age.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy with local confirmation of the presence of the EGFR exon 20 insertion mutation
- Disease progression while on standard chemotherapy (platinum doublet chemotherapy or single-agent chemotherapy in selected patients)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must have a life expectancy ≥ 12 weeks
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- 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:
- Male patients should be willing to use barrier contraception
- 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 measurable lesion
- Provision of archival FFPE tissue
- Provision of informed consent for translational genetic research
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)
- Previous treatment with osimertinib (3rd generation EGFR TKIs such as olumtinib, EGF816 etc)
- Treatment with an investigational drug within five half-lives of the compound
- 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 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.
- 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.
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- Patients with symptomatic CNS metastases who are neurologically unstable; however, those with asymptomatic CNS metastases who do not require steroids for at least 4 weeks prior to start of osimertinib are eligible.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- Inadequate bone marrow reserve or organ function
- QTc prolongation (mean resting corrected QTc > 470 msec)
- 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
- History of hypersensitivity to osimertinib (or drugs with a similar chemical structure or class to osimertinib) 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 (urine or 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
1 site in 1 country.
About this study
Official title: Phase II Study of Osimertinib in NSCLC Patients With EGFR Exon 20 Insertion Mutation
This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.
Read the detailed description
EGFR exon 20 insertion-mutant NSCLCs are generally resistant to 1st-generation EGFR tyrosine kinase inhibitors (TKIs) as well as 2nd-generation EGFR TKIs (overall response rates of 0-8.7%). Osimertinib is an oral, potent, irreversible EGFR-TKI selective for sensitizing EGFR and EGFR T790M resistance mutations with a significant selectivity margin against wild-type EGFR. Osimertinib is potent with a wide therapeutic window in Ba/F3 cells with EGFR exon 20 insertion mutations. Therefore, this study will be performed to investigate the efficacy of osimertinib in NSCLC patients with EGFR exon 20 insertion mutation
- Conditions
- Locally Advanced or Metastatic NSCLC
- Being tested
- Osimertinib 80 MG [Tagrisso]
- Keywords
- NSCLC, Osimertinib, EGFR exon 20 insertion mutation
- 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.
Osimertinib 80 MG [Tagrisso]Drug
Osimertinib 80mg once daily until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | Osimertinib at 80mg dose will be administered orally once daily. Receives: Drug: Osimertinib 80 MG [Tagrisso] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Investigator-assessed, confirmed objective response by RECIST version 1.1
Measured: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)
Secondary outcomes (3)
Serious Adverse Events
AEs/SAEs as defined by NCI CTCAE version 4.0
Measured: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawal, whichever came first. Until study completion. (upto about 29months)
Progression-free Survival
PFS as defined by RECIST version 1.1
Measured: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months)
Overall Survival
OS as defined by RECIST version 1.1. The time from the first date of IP administration to the date of death.
Measured: From the first date of IP administration to the date of death. (upto about 29months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start4 Jan 2018
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Korean Cancer Study Group
- Responsible party
- Principal investigator, Tae Min Kim, Seoul National University Hospital
- Investigators
- Tae Min Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414814
- Sponsor's protocol ID
- KCSG LU17-19
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2017
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim YJ, Kim S, Kim TM, Suh KJ, Kim M, Kim SH, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of osimertinib in patients with NSCLC harboring EGFR exon 20 insertion: A multicenter trial of the Korean Cancer Study Group (LU17-19). Lung Cancer. 2024 Aug;194:107870. doi: 10.1016/j.lungcan.2024.107870. Epub 2024 Jul 3.
PubMed 38986212
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Osimertinib in NSCLC Patients With EGFR Exon 20 Insertion Mutation
- ClinicalTrials.gov ID
- NCT03414814
- Acronym / sponsor ID
- KCSG LU17-19
- Conditions
- Locally Advanced or Metastatic NSCLC
- Keywords
- NSCLC, Osimertinib, EGFR exon 20 insertion mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca, Korean Cancer Study Group
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.
Detailed description
EGFR exon 20 insertion-mutant NSCLCs are generally resistant to 1st-generation EGFR tyrosine kinase inhibitors (TKIs) as well as 2nd-generation EGFR TKIs (overall response rates of 0-8.7%). Osimertinib is an oral, potent, irreversible EGFR-TKI selective for sensitizing EGFR and EGFR T790M resistance mutations with a significant selectivity margin against wild-type EGFR. Osimertinib is potent with a wide therapeutic window in Ba/F3 cells with EGFR exon 20 insertion mutations. Therefore, this study will be performed to investigate the efficacy of osimertinib in NSCLC patients with EGFR exon 20 insertion mutation
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: Osimertinib 80 MG [Tagrisso]Osimertinib at 80mg dose will be administered orally once daily. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of informed consent prior to any study specific procedures
- Male or female must be > 19 years of age.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy with local confirmation of the presence of the EGFR exon 20 insertion mutation
- Disease progression while on standard chemotherapy (platinum doublet chemotherapy or single-agent chemotherapy in selected patients)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (16 listed)
- Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)
- Previous treatment with osimertinib (3rd generation EGFR TKIs such as olumtinib, EGF816 etc)
- Treatment with an investigational drug within five half-lives of the compound
- 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 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.
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 |
|---|---|---|
| Osimertinib 80 MG [Tagrisso]Osimertinib 80mg once daily until disease progression | Drug | Osimertinib |
Primary outcome
Objective Response Rate
Time frame: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)
Investigator-assessed, confirmed objective response by RECIST version 1.1
3 secondary outcomes
Serious Adverse Events
Time frame: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawal, whichever came first. Until study completion. (upto about 29months)
Progression-free Survival
Time frame: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months)
Overall Survival
Time frame: From the first date of IP administration to the date of death. (upto about 29months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38986212Kim YJ, Kim S, Kim TM, Suh KJ, Kim M, Kim SH, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of osimertinib in patients with NSCLC harboring EGFR exon 20 insertion: A multicenter trial of the Korean Cancer Study Group (LU17-19). Lung Cancer. 2024 Aug;194:107870. doi: 10.1016/j.lungcan.2024.107870. Epub 2024 Jul 3.
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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.
Tae Min Kim, MD, PhD principal investigator
Seoul National University Hospital
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 80 MG [Tagrisso] in people with Locally Advanced or Metastatic NSCLC, run by Seoul National University Hospital 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 12 inclusion and 16 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 11 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2025). 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?
Objective Response Rate (time frame: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)). 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 NCT03414814, which also lists 1 linked publication.
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 11 Feb 2025.