Lung Cancer Stage IVPhase 2NCT05701384
Lazertinib 160mg in EGFR T790M NSCLC
A Phase 2 study testing Lazertinib in people with Lung Cancer Stage IV and EGFR T790M, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer Stage IV, EGFR T790M
- What is being tested?
- Lazertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2023to 31 Jan 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed non-small cell lung cancer
- Patients in a palliative setting who is not applicable for the curative treatment
- EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
- Confirmed EGFR T790M mutation after the previous EGFR TKI
- Available to receive lazertinib either as po or vis levine tube
- Willing to participate clinical trial
- Age over or equal to 19
- ECOG PS 0 to 2
Who cannot join
- Previously received 3rd generation EGFR TKI
- No clinical benefit is expected based on the investigator's decision
- Uncontrolled symptomatic CNS metastases
- Uncontrolled systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer
The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.
- Conditions
- Lung Cancer Stage IV, EGFR T790M
- Being tested
- Lazertinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LazertinibDrug
160mg po qd
| Study group | Role | What they receive |
|---|---|---|
| Lazertinib 160mg arm | Experimental | Not described Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose reduction or treatment discontinuation rate
Dose who received dosage below 160mg or discontinued due to the adverse event
Measured: Total 24 months of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Samsung 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Mu Sun, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701384
- Sponsor's protocol ID
- SMC 2023-01-17
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The only clinical outcome data will be published
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05701384
- Acronym / sponsor ID
- SMC 2023-01-17
- Conditions
- Lung Cancer Stage IV, EGFR T790M
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Jan 2023 (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.
The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lazertinib 160mg arm | Experimental | Drug: Lazertinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed non-small cell lung cancer
- Patients in a palliative setting who is not applicable for the curative treatment
- EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
- Confirmed EGFR T790M mutation after the previous EGFR TKI
- Available to receive lazertinib either as po or vis levine tube
Key exclusion criteria (4 listed)
- Previously received 3rd generation EGFR TKI
- No clinical benefit is expected based on the investigator's decision
- Uncontrolled symptomatic CNS metastases
- Uncontrolled systemic 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 |
|---|---|---|
| Lazertinib160mg po qd | Drug | Lazertinib 160mg arm |
Primary outcome
The dose reduction or treatment discontinuation rate
Time frame: Total 24 months of study period
Dose who received dosage below 160mg or discontinued due to the adverse event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No. The only clinical outcome data will be published
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lazertinib in people with Lung Cancer Stage IV and EGFR T790M, run by Samsung 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 8 inclusion and 4 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 27 Jan 2023. 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?
Results are not available in the source record.
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?
The dose reduction or treatment discontinuation rate (time frame: Total 24 months of study period). 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 Jan 2023.