Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
NCT ID: NCT05477615
Last Updated: 2022-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
28 participants
INTERVENTIONAL
2022-08-31
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible before meals. Chemotherapy will be administered on the 1st day every 3 weeks. (Pemetrexed 500mg/m2, Carboplatin AUC x 5 mg/mL.min) One cycle of treatment is defined as continuous administration for 21 days.
The treatment will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. If the investigator decides to reduce the dose due to an adverse reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to Prior Lazertinib
NCT05786430
Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
NCT05326425
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
NCT04988295
Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib
NCT04769388
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations
NCT05299125
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Intracranial objective response rate (iORR): percentage of subjects with at least one confirmed response (CR or PR or responding) in the intracranial lesion before evidence of progression in patients with brain metastases Intracranial progression free survival (iPFS): From C1D1 to the date of either disease progression of intracranial lesions or death Objective response rate (ORR): proportion of patients achieving a complete response or partial response of overall lesions Duration of response (DoR): From the first recorded response to the first recorded disease progression or death Disease control rate, (DCR): proportion of patients achieving a complete response or partial response or stable disease of overall lesions Overall survival: From C1D1 to the date of all-cause mortality Safety: Evaluated by NCI-CTCAE v5.0 Pattern of treatment failure: intracranial progression, extracranial progression, or both Intracranial salvage treatment rate: Percentage of subjects who underwent salvage treatment(surgery or radiation) due to intracranial disease progression
The exploratory objective is to identify molecular profiling using next generation sequencing.
Patients should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible before meals. Chemotherapy will be administered on the 1st day every 3 weeks. (Pemetrexed 500mg/m2, Carboplatin AUC x 5 mg/mL.min) One cycle of treatment is defined as continuous administration for 21 days.
The treatment will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. If the investigator decides to reduce the dose due to an adverse reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution. To prevent side effects of pemetrexed, start at least 7 days before cycle 1 daily dose of 350-1,000 μg/day of folic acid and 1000 μg/3 of vitamin B12.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
lazertinib/pemetrexed/carboplatin
combination of lazertinib with pemetrexed/carboplatin chemotherapy
\- Lazertinib 240mg once daily and chemotherapy (pemetrexed and carboplatin) is administered on the 1st day every 3 weeks.
Lazertinib
\- Lazertinib 240mg (3 tablets, 80mg/1tablet) once a day, oral, before disease progression
Pemetrexed
\- Pemetrexed 500mg/m2 is administered on the 1st day every 3 weeks. One cycle of treatment is defined as continuous administration for 21 days. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.
Carboplatin
\- Carboplatin AUC x 5 mg/mL.min is administered on the 1st day every 3 weeks. One cycle of treatment is defined as continuous administration for 21 days. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lazertinib
\- Lazertinib 240mg (3 tablets, 80mg/1tablet) once a day, oral, before disease progression
Pemetrexed
\- Pemetrexed 500mg/m2 is administered on the 1st day every 3 weeks. One cycle of treatment is defined as continuous administration for 21 days. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.
Carboplatin
\- Carboplatin AUC x 5 mg/mL.min is administered on the 1st day every 3 weeks. One cycle of treatment is defined as continuous administration for 21 days. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age and gender A. Male or female, 20 years of age or older B. Female patients must agree to the use of appropriate contraceptive methods and not be lactating, and for women of childbearing age, there must be evidence that the pregnancy test is negative prior to initiation of dosing, or that they are not fertile because they meet one of the following criteria at screening: box "Postmenopausal" women over the age of 50 and who are amenorrhea for at least 12 months after stopping all exogenous hormone therapy Records of irreversible surgical infertility by hysterectomy, bilateral ovariectomy, or bilateral yolk resection, tubal ligation are not permitted Women under 50 years of age had amenorrhea for at least 12 months after stopping all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) were within the postmenopausal range of the laboratory. Is only recognized as a postmenopausal condition C. Male patients who have not undergone vasectomy must consent to the use of a blocking contraception method, i.e., condom, and sperm supply is prohibited until 3 months after taking the last investigational drug D. Must be able to swallow tablets
3. Target disease A. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer patients. This may occur as systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/C or IV disease.
B. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, with no deterioration in the last 2 weeks C. Life expectancy judged by the Investigator of at least 3 months D. Disease status
* Confirmed sensitizing EGFR mutation prior to administration of osimertinib (L858R, Exon 19 deletion, G719X and L861Q mutations should be confirmed as a record)
* Failure after osimertinib. Past treatment history for locally advanced or metastatic NSCLC limited to two regimen of EGFR TKI treatment (osimertinib and/or gefitinib, erlotinib, or afatinib) and/or one palliative cytotoxic chemotherapy regimen (A wash-out period of at least 2 months is required until administration after the last dose of osimertinib)
* Asymptomatic or mild symptomatic brain metastases progressed or newly confirmed patients
* One or more intracranial measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). The target lesion that has received previous local therapy should not be considered as measurable. However, new CNS lesion after more than 3 months of previous local therapy could be considered as target lesion.
Exclusion Criteria
H. Previous anticancer treatment-related toxicities not recovered to baseline or Grade 0-1 (except alopecia) 2) Medical history and current disease A. Symptomatic spinal cord compression (However, registration is allowed if steroid treatment is not required within at least 2 weeks before the start of administration of the investigational drug) B. Symptomatic and unstable central nervous system (CNS) or brain metastasis requiring local treatment at screening. (Asymptomatic or mild symptomatic leptomeningeal metastasis is also permitted to be registered) C. Symptomatic or intracranial bleeding that needs treatment D. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD E. Carcinoma other than non-small cell lung cancer, if the investigator is judged to be inadequate to participate in this clinical trial due to evidence of severe or uncontrolled systemic disease, uncontrolled hypertension, or active bleeding tendency, or that it is difficult to follow this protocol. (Screening for chronic disease is not required)
F. Any of the following cardiovascular diaseases:
i. A history of congestive heart failure (CHF) of grade 3 or higher according to the New York Heart Association Classification (NYHA) or cardiac arrhythmia requiring treatment ii. A History of unstable angina or myocardial infarction experienced within 6 months before the first administration of the investigational drug iii. Left ventricular ejection fraction \<45% on recent echocardiography or MUGA scan G. Known human immunodeficiency virus (HIV) infection H. Patients with refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow the product, or undergoing enterectomy deemed to interfere with the proper absorption of lazertinib.
I. History of hypersensitivity to drugs J. Clinically significant chronic infection or major medical or mental illness K. Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the study at the discretion of the Investigators L. History of allogeneic hematopoietic stem cell transplantation, history of whole blood transfusions that did not remove leukocytes within 120 days before the date of collection of genetics specimens 3) Criteria for cardiology and clinical laboratory testing
A. Cardiac criteria in any of the following:
i. Based on the QTc value measured with an electrocardiogram (ECG) device during screening, the average of the correction of the QT interval (QTc) at rest on an electrocardiogram (ECG) measured three times\> 470 msec ii. Clinically important abnormalities of rhythm, conduction, or shape on the ECG at rest. For example, complete left block, 3rd degree cardiac block, 2nd degree cardiac block, PR interval\> 250 msec iii. Increased risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital QT prolongation syndrome, concomitant medications known to prolong QT intervals, QT prolongation syndrome or a family history of unexplained sudden deaths under 40.
B. Laboratory index at baseline:
iv. Hemoglobin ≤ 8.0 g/dL (without transfusion or growth factor support in the preceding 14 days) v. Neutrophils \< 1.0 x 109/L vi. Platelets \< 100 x 109/L (without transfusion or growth factor support in the preceding 7 days) vii. Total bilirubin \> 3 mg/dL viii. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN) ix. Renal impairment as evidenced by serum creatinine ≥ 1.5 x ULN, or calculated creatinine clearance (CrCl) \< 50 mL/min by Cockroft-Gault formula (24-hour CrCl might be requested by the Investigator for confirmation, if calculated CrCl is \< 60 mL/min. In such case, subjects with 24-hour CrCl \< 50 mL/min should be excluded)
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Korea University Anam Hospital
OTHER
Jin Hyoung Kang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jin Hyoung Kang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jin Hyoung Kang
Role: STUDY_CHAIR
Seoul St. Mary's Hospital, The Catholic University of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gachon University Gil Medical Center
Gyeonggi-do, , South Korea
Incheon St. Mary's hospital, Catholic university of Korea
Incheon, , South Korea
Gachon University Gil Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hosptial
Seoul, , South Korea
Seoul St. Mary's Hospital, Catholic University of Korea
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LU21-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.