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Compares treatment options for Lazertinib
Official title A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker
ClinicalTrials.gov ID: NCT06156527
What this study is testing
What is Lazertinib?
Lazertinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for lazertinib.
Also referred to as Single arm, combinationarm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Histologically confirmed patients with locally progressive or metastatic non-small cell lung cancer (IIIB or IV) who have not been diagnosed as...
- Patients with one or more measurable lesions in accordance with the RECIST criteria (Version 1.1), tumor lesions located at the previous irradiation...
- 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...
- ECOG PS 0-1 Patient
You likely can't join if
- \- 1) Patients with other malignant tumors except lung cancer within the past three years (except for properly treated cervical epithelial cancer...
- Average of corrected QT intervals at rest (QTc intervals corrected by Fredericia formula) \>470 msec based on QTc values calculated by ECG equipment...
- clinically significant abnormal findings found in the rhythm, conduction, or morphology of the ECG at rest (e.g., complete left block, 3rd degree...
- All factors that increase the risk of QTc prolongation or arrhythmia, including heart failure, hypokalemia, family history of congenital QT...
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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...
- 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 people 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...
- 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-
- \- 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...
- 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)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Suwon, Gyeonggi-do, South Korea
- Goyang-si, Gyeunggi-do, South Korea
- Suwon, Gyeunggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suwon, Gyeonggi-do, South Korea; Goyang-si, Gyeunggi-do, South Korea; Suwon, Gyeunggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.