LazertinibPhase 2NCT06156527
A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker
A Phase 2 study testing Lazertinib and Bevacizumab Injectable Product in people with Lazertinib, run by National Cancer Center, Korea at 5 sites in South Korea.
Trial summary
Using gefitinib or Osimertinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with active mutations in epithelial cell growth factor receptors (EGFR), 70% response rate (CR+PR) and 90% disease control rate (CR+PR+SD) compared to the current non-small cell therapy, which is significant in the EFRT treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lazertinib
- What is being tested?
- Lazertinib and Bevacizumab Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 5 Sep 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed patients with locally progressive or metastatic non-small cell lung cancer (IIIB or IV) who have not been diagnosed as squamous cell carcinoma.
- Patients with one or more measurable lesions in accordance with the RECIST criteria (Version 1.1), tumor lesions located at the previous irradiation site, are considered measurable if progress has been made in those lesions.
- Patients with institutionalized EGFR mutation (exon 19 deletion or L858R)
- Patients with a history of smoking, including those who are currently smoking (defined as those who have smoked more than 100 cigarettes in their lifetime)
- ECOG PS 0-1 Patient
- Patients with appropriate hematological functions ANC≥1,500/uL, hemoglobin≥9.0g/dL, platelet≥100,000/uL
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- Patients with adequate liver function Total bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL (If there is an interruption: total bilirubin <3 x UNL, AST (SGOT) and ALT (SGPT) <5 x UNL)
- a patient with appropriate renal function Cr UN UNL, however, can be registered if the creatinine clearance calculated according to the formula Cocroft and Gault is 50 50 ml/min outside the normal range.
- Proteinuria test <2+ (if 22+ then protein 11g must be in 24-hour urine test)
- Patients with a history of receiving radiation therapy must meet the following criteria.
- In the case of direct radiation irradiation to the lung lesion area, it must have elapsed at least 12 weeks from the time of registration.
- In the case of chronic radiation therapy for intracoracic bone metastasis, it must be at least 12 weeks from the time of registration.
- 2 weeks or more from the time of registration if radiotherapy has been performed on any non-chest area Must be elapsed.
- At the time of registration, the date of completion of the previous treatment or procedure must pass the period specified below.
- Surgery (including exploratory/experimental thoracotomy): 4 weeks
- Pericardial drainage: 1 week
- pleural adhesion not attributed to anti-species positive substances (including biological response regulators such as Picibanil): 2 weeks
- Tissue biopsy to confirm selection criteria (including biopsy using thoracoscope): 1 week
- Procedures for the treatment of trauma (unregistered patients with untreated wounds): 2 weeks
- Blood transfusion, hematopoietic growth factor administration: 2 weeks
- The puncture and aspiration cell test: 1 week
- Administration of other clinical trial medications: 4 weeks
- Women in childbearing age should be negative in serum or urine pregnancy tests within 7 days prior to test treatment.
- Male and childbearing female test subjects with female partners' pregnancy must agree to use the following two high-efficiency test methods for at least 180 days after the last dose of the assigned treatment is administered. Bevacizumab can also damage a woman's reproductive ability. Therefore, women who have entered the bevacizumab combination group should be preceded by discussions on preserving the reproductive ability of women who are likely to become pregnant before treatment - asceticism
- tubal ligation
- Hormone contraceptives that do not cause drug interactions (such as Mirena)
- Medroxyprogesterone injection (Depo-Provera)
- Copper bands and intrauterine devices
- a partner's vasectomy
- Partner's use of condoms
- Patients who have agreed to the clinical trial-
Who cannot join
- 1) Patients with other malignant tumors except lung cancer within the past three years (except for properly treated cervical epithelial cancer, basal or squamous cell skin cancer, thyroid cancer, and topical prostate cancer surgically treated for healing purposes).
- 2) Patients with a history of bleeding above Grade 2 (with blood above Grade 2) 2.5mL within 3 months of registration defined as the above bright red blood.) 3) chemotherapy for advanced lung cancer in the past or other systemic anticancer drugs (single-clone antibodies or Patients with tyrosine kinase inhibitors) (However, pre- and post-operative assisted chemotherapy, which ended 6 months before the time of registration, is allowed.) 4) A patient with evidence of invasion of large blood vessels, such as the pulmonary artery or relative vein of a tumor, in contrast examination.
- 5) Patients scheduled to undergo hydrophobic surgery (including infantile catheter insertion) within 24 hours of the first injection of bevacizumab 6) Current or recent (within 10 days prior to the initial injection of bevacizumab) aspirin (>325 mg/day) and patients with oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (provided that preventive use of anticoagulants is permitted).) 7) Patients currently in use (or unable to discontinue prior to the initial dose of lazertinib) with a drug or natural aid known as a potent CYP3A4 inducer that cannot be discontinued throughout clinical trials before enrollment 8) Any evidence of ILD, drug-induced ILD, past history of radiation interstitial pneumonia requiring steroid treatment, or clinically active ILD 9) Patients undergoing or likely to administer bisphosphonate medication 10) Uncontrolled patients with brain-spinal metastasis (Patients with epilepsy can be registered if they are stabilized asymptomaticly, and treated patients with epilepsy can be registered if they do not currently require steroid treatment.) 11) Patients with clinically significant ophthalmic abnormalities on the surface of the eye (not recommended to use contact lenses) (with corneal perforations or ulcers, symptoms and signs of acute or exacerbated corneal inflammation such as ocular inflammation, tear secretion, blurred vision, eye pain and bleeding) 12) Patients with a history of coagulopathy with hereditary bleeding constitution or risk of bleeding 13) Patients with uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic >100 mmHg) 14) Patients with clinically significant active cardiovascular disease (within 6 months of registration, patients with cerebrovascular accidents and diseases, myocardial infarction, unstable angina, NYHA ClassIIII congestive heart failure, thrombosis, thromboembolism, and severe cardiac arrhythmia that may interfere with drug administration during clinical trials)
- The following heart criteria are not limited to one. :
- Average of corrected QT intervals at rest (QTc intervals corrected by Fredericia formula) >470 msec based on QTc values calculated by ECG equipment by the test institution during screening.
- clinically significant abnormal findings found in the rhythm, conduction, or morphology of the ECG at rest (e.g., complete left block, 3rd degree heart block, 2nd degree heart block)
Show all 10Show fewer
- All factors that increase the risk of QTc prolongation or arrhythmia, including heart failure, hypokalemia, family history of congenital QT prolongation syndrome, sudden death of causes under the age of 40 in the immediate family, combined drugs known to prolong QT spacing and induce Torsades de Points (TdP).
- 15) Patients with non-healing wounds, active digestive ulcers, or fractures 16) Patients with active infections and uncontrolled systemic diseases 17) Patients who have a chemical structure similar to lasertinib and bevacizumab or these substances or who have a history of hypersensitivity to active ingredients or inactive excipients of drugs belonging to the family.
- 18) Patients who are hypersensitive to CHO (animal cell line from the uterus of Chinese hamsters) cell products or other recombinant human body or humanized antibodies.
- 19) Pregnant or lactating women
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeunggi-do, 10408
Beung-Chul AHN, +82-31-920-1676, abcduke@ncc.re.kr
- Not yet recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Min Hee Hong, Ph,D., 82-02-2227-8068, minhee_hong@yuhs.ac
- Not yet recruiting
Gangnam Severance Hospita
Seoul, 06273
Seoyoung Lee, Ph.D, +82-31-920-3509, sylee88@yuhs.ac
- Not yet recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Byoung-Yong Shim, Ph.D, +82-31-249-8016, shimby@catholic.ac.kr
- Not yet recruiting
AJOU university hospital
Suwon, Gyeunggi-do, 16499
Hyunwoo lee, Ph.D, +82-31-1688-6114, leehw@ajou.ac.kr
About this study
Official title: A Randomized Phase II Study of LAZE Rti N ib Alone Versus Lazertinib Plus Beva C Izumab for A Dvanced Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations and Smoking History
Using gefitinib or Osimertinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with active mutations in epithelial cell growth factor receptors (EGFR), 70% response rate (CR+PR) and 90% disease control rate (CR+PR+SD) compared to the current non-small cell therapy, which is significant in the EFRT treatment. However, resistance causes recurrence in most patients. Therefore, it is necessary to develop a more effective treatment. Recently, in Japan, combined allotinib and bevacizumab therapy as primary therapy in non-small cell lung cancer patients with EGFR mutation improved PFS statistically significantly compared to allotinib monotherapy, suggesting the possibility of a new treatment (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). In addition, subsequent osmutinib and bevacizumab combination therapy showed a significant difference in PFS in the smoker group, although they did not show significant improvement in PFS in the entire patient group. (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). Since EGFR mutated lung cancer is highly frequent in Korea, it is necessary to develop more effective treatments for such patients. Therefore, we propose this clinical trial to find out the efficacy of lasertinib and bevacizumab combination therapy.
Read the detailed description
The primary objective of this study was to evaluate PFS of laseratinib and bevacizumab combination therapy as the primary treatment for advanced lung cancer with EGFR mutation.
For laseratinib monotherapy, the expected median PFS is 15 months. On the other hand, assuming the expected median PFS 27 months of laseratinib and bevacizumab combination therapy, the one-sided test alpha level is 0.05, the power 0.8) dropout rate should be approximately 120 (60 people per group) enrolled in this study.
Patients would be enrolled in this study for 18 months and followed up to at least 24 months from the last patient enrollment date.
This study is a phase 2 clinical trial, and the primary goal is PFS, and based on the log rank test, the laseratinib bevacizumab combination therapy group significantly increases PFS when one side p value <0.05.
Fisher's Fisher exact test or chi-square test will be used in consideration of laboratory data and laboratory test abnormalities or clinical adverse reactions.
- Conditions
- Lazertinib
- Being tested
- Lazertinib, Bevacizumab Injectable Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LazertinibDrug
Also called Single arm, combinationarm
Lazertinib 240mg, QD, daily
Bevacizumab Injectable ProductDrug
Also called combinationarm
Bevacizumab: 15mg/kg IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| single arm | Active comparator | lazertinib single arm Receives: Drug: Lazertinib |
| combination arm | Experimental | Lazertinib plus bevacizumab Receives: Drug: Lazertinib; Drug: Bevacizumab Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression -free survival
Measured: every 9 weeks
Secondary outcomes (3)
ORR
Overall Response Rate
Measured: every 9 weeks
OS
Overall Survival
Measured: 2 years after randomization
AE
Safety
Measured: every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start5 Sep 2023
- Primary completion5 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LazertinibStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Beung-Chul AHN, National Cancer Center, Korea
- Investigators
- Beung-Chul AHN, Study chair, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156527
- Sponsor's protocol ID
- LAZENCA Trial
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of LAZE Rti N ib Alone Versus Lazertinib Plus Beva C Izumab for A Dvanced Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations and Smoking History
- ClinicalTrials.gov ID
- NCT06156527
- Acronym / sponsor ID
- LAZENCA Trial
- Conditions
- Lazertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 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.
Using gefitinib or Osimertinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with active mutations in epithelial cell growth factor receptors (EGFR), 70% response rate (CR+PR) and 90% disease control rate (CR+PR+SD) compared to the current non-small cell therapy, which is significant in the EFRT treatment. However, resistance causes recurrence in most patients. Therefore, it is necessary to develop a more effective treatment. Recently, in Japan, combined allotinib and bevacizumab therapy as primary therapy in non-small cell lung cancer patients with EGFR mutation improved PFS statistically significantly compared to allotinib monotherapy, suggesting the possibility of a new treatment (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). In addition, subsequent osmutinib and bevacizumab combination therapy showed a significant difference in PFS in the smoker group, although they did not show significant improvement in PFS in the entire patient group. (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). Since EGFR mutated lung cancer is highly frequent in Korea, it is necessary to develop more effective treatments for such patients. Therefore, we propose this clinical trial to find out the efficacy of lasertinib and bevacizumab combination therapy.
Detailed description
The primary objective of this study was to evaluate PFS of laseratinib and bevacizumab combination therapy as the primary treatment for advanced lung cancer with EGFR mutation.
For laseratinib monotherapy, the expected median PFS is 15 months. On the other hand, assuming the expected median PFS 27 months of laseratinib and bevacizumab combination therapy, the one-sided test alpha level is 0.05, the power 0.8) dropout rate should be approximately 120 (60 people per group) enrolled in this study.
Patients would be enrolled in this study for 18 months and followed up to at least 24 months from the last patient enrollment date.
This study is a phase 2 clinical trial, and the primary goal is PFS, and based on the log rank test, the laseratinib bevacizumab combination therapy group significantly increases PFS when one side p value <0.05.
Fisher's Fisher exact test or chi-square test will be used in consideration of laboratory data and laboratory test abnormalities or clinical adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single arm | Active comparator | Drug: Lazertiniblazertinib single arm |
| combination arm | Experimental | Drug: Lazertinib, Drug: Bevacizumab Injectable ProductLazertinib plus bevacizumab |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Histologically confirmed patients with locally progressive or metastatic non-small cell lung cancer (IIIB or IV) who have not been diagnosed as squamous cell carcinoma.
- Patients with one or more measurable lesions in accordance with the RECIST criteria (Version 1.1), tumor lesions located at the previous irradiation site, are considered measurable if progress has been made in those lesions.
- Patients with institutionalized EGFR mutation (exon 19 deletion or L858R)
- Patients with a history of smoking, including those who are currently smoking (defined as those who have smoked more than 100 cigarettes in their lifetime)
- ECOG PS 0-1 Patient
Key exclusion criteria (10 listed)
- 1) Patients with other malignant tumors except lung cancer within the past three years (except for properly treated cervical epithelial cancer, basal or squamous cell skin cancer, thyroid cancer, and topical prostate cancer surgically treated for healing purposes).
- 2) Patients with a history of bleeding above Grade 2 (with blood above Grade 2) 2.5mL within 3 months of registration defined as the above bright red blood.) 3) chemotherapy for advanced lung cancer in the past or other systemic anticancer drugs (single-clone antibodies or Patients with tyrosine kinase inhibitors) (However, pre- and post-operative assisted chemotherapy, which ended 6 months before the time of registration, is allowed.) 4) A patient with evidence of invasion of large blood vessels, such as the pulmonary artery or relative vein of a tumor, in contrast examination.
- 5) Patients scheduled to undergo hydrophobic surgery (including infantile catheter insertion) within 24 hours of the first injection of bevacizumab 6) Current or recent (within 10 days prior to the initial injection of bevacizumab) aspirin (>325 mg/day) and patients with oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (provided that preventive use of anticoagulants is permitted).) 7) Patients currently in use (or unable to discontinue prior to the initial dose of lazertinib) with a drug or natural aid known as a potent CYP3A4 inducer that cannot be discontinued throughout clinical trials before enrollment 8) Any evidence of ILD, drug-induced ILD, past history of radiation interstitial pneumonia requiring steroid treatment, or clinically active ILD 9) Patients undergoing or likely to administer bisphosphonate medication 10) Uncontrolled patients with brain-spinal metastasis (Patients with epilepsy can be registered if they are stabilized asymptomaticly, and treated patients with epilepsy can be registered if they do not currently require steroid treatment.) 11) Patients with clinically significant ophthalmic abnormalities on the surface of the eye (not recommended to use contact lenses) (with corneal perforations or ulcers, symptoms and signs of acute or exacerbated corneal inflammation such as ocular inflammation, tear secretion, blurred vision, eye pain and bleeding) 12) Patients with a history of coagulopathy with hereditary bleeding constitution or risk of bleeding 13) Patients with uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic >100 mmHg) 14) Patients with clinically significant active cardiovascular disease (within 6 months of registration, patients with cerebrovascular accidents and diseases, myocardial infarction, unstable angina, NYHA ClassIIII congestive heart failure, thrombosis, thromboembolism, and severe cardiac arrhythmia that may interfere with drug administration during clinical trials)
- Average of corrected QT intervals at rest (QTc intervals corrected by Fredericia formula) >470 msec based on QTc values calculated by ECG equipment by the test institution during screening.
- clinically significant abnormal findings found in the rhythm, conduction, or morphology of the ECG at rest (e.g., complete left block, 3rd degree heart block, 2nd degree heart block)
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 |
|---|---|---|
| LazertinibAlso: Single arm, combinationarmLazertinib 240mg, QD, daily | Drug | combination arm, single arm |
| Bevacizumab Injectable ProductAlso: combinationarmBevacizumab: 15mg/kg IV every 3 weeks | Drug | combination arm |
Primary outcome
PFS
Time frame: every 9 weeks
Progression -free survival
3 secondary outcomes
ORR
Time frame: every 9 weeks
OS
Time frame: 2 years after randomization
AE
Time frame: every 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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.
Beung-Chul AHN study chair
National Cancer Center
5 sites 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 and Bevacizumab Injectable Product in people with Lazertinib, run by National Cancer Center, Korea at 5 sites 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 31 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beung-Chule AHN (+82-31-920-1676, abcduke@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: every 9 weeks). 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 5 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.