Non-small Cell Lung CancerPhase 2LUCASNCT05786430
Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to Prior Lazertinib
A Phase 2 study testing Lazertinib/Pemetrexed/Carboplatin in people with Non-small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This trial is Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients with EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to prior lazertinib. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Lazertinib/Pemetrexed/Carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2023to 23 Aug 2026
- 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
- Written consent;
- A patient who voluntarily provided a written consent form before participating in a clinical trial;
- A patient who voluntarily provided written consent for genetic research for genetics and/or exploratory research
- Age and gender
- Those over 20 years old
- Female patients should agree to use proper contraception and should not be breastfeeding, and for women of childbearing age, there should be evidence that pregnancy is negative before the start of administration or satisfies one of the following criteria for screening A woman who is over 50 years of age and has amenorrhea for at least 12 months after she stops all foreign hormone treatments Record of irreversible surgical infertility by hysterectomy, bilateral hysterectomy, or bilateral hysterectomy, tubal ligation is not allowed Women under the age of 50 remain in a state of amenorrhea for at least 12 months after stopping all foreign hormone therapy, and their luteinizing hormone (LH) and follicular-stimulating hormone (FSH) levels are within the range of menopause
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- Male patients who have not undergone vasectomy must agree to blocking contraception, that is, the use of condoms, and are prohibited from providing sperm up to three months after the last clinical trial
- Target disease a) Patients with locally progressive or metastatic non-small cell lung cancer identified histologically or cytologically b) Eastern Oncology Cooperative Group (ECOG) Performance Status 0~2 c) Patient with at least three months of life expectancy A patient with at least one measurable lesion according to RECIST v1.1 criteria (the area that has received previous local treatment cannot be a target lesion. However, if three months have passed since the previous local treatment and the progression of the lesion is confirmed, it can be regarded as a target lesion.) e) Patients with EGFR mutations identified before administration of Lazertinib (L858R, Exon 19 deletion mutations must be confirmed by record) f) Patients who fail Lazertinib treatment (including all of the following cases)
- Patient using Lazertinib as the primary treatment - A patient using Lazertinib after failing one kind of first- and second-generation EGFR TKI (Gefitinib, erlotinib, afatinib)
Who cannot join
- The following interventional treatment
- Patients who received cytotoxic anticancer drugs for the treatment of advanced non-small cell lung cancer within 14 days before the first administration of the drug for clinical trial (excluding EGFR TKI-based and targeted treatments) Patients who received local treatment within four weeks of the first administration of a clinical trial drug (e.g. major surgery, radiation therapy (excluding a limited range of high-purpose bone radiation therapy), hepatic arterioembolization, catheter artery chemoembolization, chemoembolization, high-frequency resection, percutaneous ethanol injection or refrigeration)
- Note: Conventional bone-oriented radiation therapy must be done only for mitigation within a limited radiation area. It must be a short-term course according to the recommendations of the testing agency, and must be completed at least seven days before the first administration of a clinical trial drug.
- A patient who is currently receiving a drug or herbal supplement known as an inhibitor or induction of CYP3A4 or cannot be discontinued at least one week before the first administration of lazertinib Except for alopecia, toxic patients with previous treatments exceeding the unresolved CTCAE 2 grade at the time of initial administration of clinical trial drugs e) A patient with a history of using cytotoxic anticancer drugs with Palliative treatment
- Medical history and current disease l) intracranial metastasis with symptoms or requiring treatment (it must be completed at least two weeks before the first injection date of a drug for clinical trial, if steroid treatment is required). If the training membrane metastasis is asymptomatic or mild, it can be registered at the judgment of the patient
- Intracranial bleeding with symptoms or needs treatment b) Past history of interstitial lung disease (ILD), pharmacogenetic ILD, radiation pneumonia requiring steroid treatment, or ILD with evidence of clinical activity c) Diseases determined to be significant by researchers, including a history of other malignant diseases except for non-small cell lung cancer within the last three years (exception: treated cervical epithelial cancer, differentiated thyroid cancer without lymph node metastasis, skin cancer other than lymph node metastasis), evidence of severe or uncontrolled systemic diseases, uncontrolled high blood pressure and bleeding; d) The following cardiovascular diseases
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- History of congestive heart failure (CHF) of Grade 3 or higher or heart arrhythmia requiring treatment according to the New York Heart Association Classification (NYHA) criteria
- History of unstable angina or myocardial infarction experienced within six months prior to the first administration of clinical trial drugs e) Test results of known human immunodeficiency virus (anti-HIV Ab) are positive Patients with hepatitis B (HBV) surface antigen (HBsAg) positive, hepatitis C antibody (anti-HCV) positive, and other clinically active infectious liver disease, e.g. patients with a history of HCV, can be registered if antiviral therapy is completed and subsequently recorded in a document that HCV RNA is below the minimum quantitative limit. In the case of HBsAg positive, in the case of a negative polymerase chain reaction to HBV DNA g) Intractable nausea and vomiting, gastrointestinal diseases, patients who cannot be taken orally, and absorption disorders that are deemed to interfere with the absorption of Lazertinib However, if a colonectomy is performed and does not involve clinically meaningful absorption disorders according to the researcher's judgment, research registration is possible h) A known history of hypersensitivity in clinical trial drugs
- clinically significant chronic infection or major medical or mental illness j) In a case where it is determined based on the researcher's judgment that the patient should not participate in the clinical trial because the patient is unlikely to be able to comply with the clinical trial procedures, restrictions and requirements
- Heart and clinical laboratory test criteria:
- Any of the following heart criteria:
- Based on QTc levels measured by electrocardiogram (ECG) equipment during screening, QT interval (QTc) correction average > 470 msec As long as the clinical significance of rhythm, conduction, or form on the ECG during the break. For example, full left angle blocking, 3 degree heart blocking, 2 degree heart blocking, PR interval > 250 msec All factors that increase the risk of QTc extension or arrhythmia, such as heart failure, hypokalemia, congenital QT extension syndrome, combination medication known to extend the QT interval, QT extension syndrome, or family history of unexplained sudden death under the age of 40.
- Inadequate bone marrow reserve or organ function identified by the following experimental figures:
- ANC <1.0 x 109/L Platelet count <100 x 109/L Hemoglobin <80 g/L
- alanine amino transferase (ALT) > 5 x ULN
- Aspartic acid amino transferase (AST) > 5 x ULN Total bilirubin > 3 x ULN If the serum level exceeds 1.5 x ULN, the estimated cleaning rate measured using the institutional standard method (e.g., the value calculated by the Cockcroft \& Gault equation) is less than 45ml/min
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to Prior Lazertinib (LUCAS)
This trial is Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients with EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to prior lazertinib.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Lazertinib/Pemetrexed/Carboplatin
- 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.
Lazertinib/Pemetrexed/CarboplatinDrug
Combination of lazertinib 240 mg (80 mg, 3 tablets) and pemed-S + carboplatin. Once a day lazertinib 240 mg pemed-S: 500mg/m2 q3w carboplatin: AUC5 q3w (only administered up to 4 cycles)
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Not described Receives: Drug: Lazertinib/Pemetrexed/Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, PFS
PFS is defined as the period from the date of administration of the first clinical trial drug to the progression of the disease or death for any reason.
The progression-free survival period is analyzed for groups that can be evaluated for validity.
Measured: End of trial (approximately 3 years)
Secondary outcomes (5)
Overall Survival, OS
Overall Survival, OS The overall survival period (OS) is evaluated based on the date of administration of the drug for the first clinical trial and the state of survival at the time of analysis. The total survival period is defined as the period from the date of administration of the first clinical trial drug to the date of death regardless of the cause.
The entire survival period is analyzed for the safety analysis group. The total duration of survival is presented in a graph of Kaplan-Meier. Summarize the number of events, median values (calculated in Kaplan Meier graphs), and the percentage of test subjects whose events have not occurred in the 6th, 12th, and 18th months. Death, survival tracking, tracking failures, and the number and percentage of test subjects who withdrew consent are properly summarized.
Measured: End of trial (approximately 3 years)
Objective Response Rate, ORR
Objective Response Rate, ORR) ORR is defined as the percentage of test subjects whose confirmed response was (RECIST 1.1) at least one full response (Complete Response, CR) or partial response (Partial Response, PR) before evidence of disease progression appears.
The objective response rate is summarized for groups that can be evaluated for validity. The objective response rate is presented with a 95% confidence interval on both sides (assuming a normal distribution).
Measured: End of trial (approximately 3 years)
Duration of Response, DoR
Duration of response (Duration of Response, DoR) DoR is defined as the time of occurrence from the date on which a later confirmed reaction was first recorded to the date on which the disease progress was recorded or the date of death (the same as the date of occurrence of the PFS event). The start of the reaction is defined as the most recent visit date identified as the first visit response PR or CR. If the disease has not progressed after the test subject has reached the reaction, the duration of the reaction is calculated using the time of PFS intermediate amputation.
The duration of the response is analyzed for the sub-group of subjects who are CR/PR whose best overall response is confirmed among the groups that can be evaluated for validity.
Measured: End of trial (approximately 3 years)
Disease Control Rate, DCR
Disease control rate (Disease Control Rate, DCR) The disease control rate (DCR) is defined as the Best Overall Response (BOR), and the percentage of test subjects whose extracranial and intracranial responses are CR, PR, responding, or SD.
The disease control rate is summarized for groups that can be evaluated for efficacy.
The disease control rate is presented with a 95% confidence interval on both sides (assuming normal distribution).
Measured: End of trial (approximately 3 years)
Treatment failure pattern
Treatment failure pattern (Treatment failure pattern) For the pattern of treatment failures, both intracranial disease progression (Intracranial progression) and non-cranial disease progression (Extracranial progression) are divided into progress and recorded and analyzed.
Patterns of treatment failure and overall survival following locoregional failure or distant metastasis. It will be checked through RECIST every 8 weeks, confirmed as RECIST 1.1. Overall survival is analyzed in the safety analysis group. Overall survival is presented as a Kaplan-Meier graph.
Measured: End of trial (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start7 Apr 2023
- Primary completion23 Aug 2026
- Study completion23 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gon Kim, Yonsei University
- Investigators
- Hye Ryun Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786430
- Sponsor's protocol ID
- 4-2022-1142
- Acronym
- LUCAS
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to Prior Lazertinib (LUCAS)
- ClinicalTrials.gov ID
- NCT05786430
- Acronym / sponsor ID
- LUCAS / 4-2022-1142
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 23 Aug 2026 (actual)
- Study completion
- 23 Aug 2026 (actual)
- First posted
- 27 Mar 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.
This trial is Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients with EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to prior lazertinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: Lazertinib/Pemetrexed/Carboplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written consent;
- Age and gender
- Target disease a) Patients with locally progressive or metastatic non-small cell lung cancer identified histologically or cytologically b) Eastern Oncology Cooperative Group (ECOG) Performance Status 0~2 c) Patient with at least three months of life expectancy A patient with at least one measurable lesion according to RECIST v1.1 criteria (the area that has received previous local treatment cannot be a target lesion. However, if three months have passed since the previous local treatment and the progression of the lesion is confirmed, it can be regarded as a target lesion.) e) Patients with EGFR mutations identified before administration of Lazertinib (L858R, Exon 19 deletion mutations must be confirmed by record) f) Patients who fail Lazertinib treatment (including all of the following cases)
- Patient using Lazertinib as the primary treatment - A patient using Lazertinib after failing one kind of first- and second-generation EGFR TKI (Gefitinib, erlotinib, afatinib)
Key exclusion criteria (16 listed)
- The following interventional treatment
- A patient who is currently receiving a drug or herbal supplement known as an inhibitor or induction of CYP3A4 or cannot be discontinued at least one week before the first administration of lazertinib Except for alopecia, toxic patients with previous treatments exceeding the unresolved CTCAE 2 grade at the time of initial administration of clinical trial drugs e) A patient with a history of using cytotoxic anticancer drugs with Palliative treatment
- Medical history and current disease l) intracranial metastasis with symptoms or requiring treatment (it must be completed at least two weeks before the first injection date of a drug for clinical trial, if steroid treatment is required). If the training membrane metastasis is asymptomatic or mild, it can be registered at the judgment of the patient
- History of unstable angina or myocardial infarction experienced within six months prior to the first administration of clinical trial drugs e) Test results of known human immunodeficiency virus (anti-HIV Ab) are positive Patients with hepatitis B (HBV) surface antigen (HBsAg) positive, hepatitis C antibody (anti-HCV) positive, and other clinically active infectious liver disease, e.g. patients with a history of HCV, can be registered if antiviral therapy is completed and subsequently recorded in a document that HCV RNA is below the minimum quantitative limit. In the case of HBsAg positive, in the case of a negative polymerase chain reaction to HBV DNA g) Intractable nausea and vomiting, gastrointestinal diseases, patients who cannot be taken orally, and absorption disorders that are deemed to interfere with the absorption of Lazertinib However, if a colonectomy is performed and does not involve clinically meaningful absorption disorders according to the researcher's judgment, research registration is possible h) A known history of hypersensitivity in clinical trial drugs
- Heart and clinical laboratory test criteria:
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 |
|---|---|---|
| Lazertinib/Pemetrexed/CarboplatinCombination of lazertinib 240 mg (80 mg, 3 tablets) and pemed-S + carboplatin. Once a day lazertinib 240 mg pemed-S: 500mg/m2 q3w carboplatin: AUC5 q3w (only administered up to 4 cycles) | Drug | experimental arm |
Primary outcome
Progression-free survival, PFS
Time frame: End of trial (approximately 3 years)
PFS is defined as the period from the date of administration of the first clinical trial drug to the progression of the disease or death for any reason. The progression-free survival period is analyzed for groups that can be evaluated for validity.
5 secondary outcomes
Overall Survival, OS
Time frame: End of trial (approximately 3 years)
Objective Response Rate, ORR
Time frame: End of trial (approximately 3 years)
Duration of Response, DoR
Time frame: End of trial (approximately 3 years)
Disease Control Rate, DCR
Time frame: End of trial (approximately 3 years)
Treatment failure pattern
Time frame: End of trial (approximately 3 years)
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hye Ryun Kim principal investigator
Severance 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 Lazertinib/Pemetrexed/Carboplatin in people with Non-small Cell Lung Cancer, run by Yonsei University 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 9 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 7 Oct 2026. 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?
Progression-free survival, PFS (time frame: End of trial (approximately 3 years)). 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 7 Oct 2026.