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New treatment option for Non Small Cell Lung Cancer
Official title Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
ClinicalTrials.gov ID: NCT05469022
What this study is testing
What is Neoadjuvant lazertinib?
Neoadjuvant lazertinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Neoadjuvant LECLAZA.
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
- Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 19 years
- Patients with suspected lung cancer on chest CT findings
- Patients with the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene...
- Patients whose tumor can be completely resected by surgery: patients with stage I-IIIB, or stage IVA who has single metastasis
- Patients not previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib
You likely can't join if
- Uncontrolled active interstitial lung disease
- Pathologically confirmed N3 disease
- Uncontrolled stage III-IV other malignancy
- Uncontrolled Hypertension, Congestive Heart failure with New York Heart Association(NYHA) ≥ 3, acute myocardial infarct history within 6 months...
- Gastrointestinal diseases (e.g. Chron's disease, ulcerative colitis) or malabsorption syndrome that would impact on drug absorption
- Active infection requiring ongoing treatment(e.g. active Hepatitis B virus, Hepatitis C virus or Human immunodeficiency virus)
See the full eligibility criteria
- Age ≥ 19 years
- Patients with suspected lung cancer on chest CT findings
- Patients with the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)
- Patients whose tumor can be completely resected by surgery: patients with stage I-IIIB, or stage IVA who has single metastasis
- Patients not previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib
- Patients with the measurable lesion of 1 cm or more according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) 0-1
- EGFR-TKIs (gefitinib, erlotinib, afatinib,dacomitinib) naive patients
- Patients with adequate pulmonary and heart function for surgery
- Adequate organ function defined as Hemoglobin ≥ 9.0g/dL Absolute neutrophil count ≥ 1500/mm3 Platelet ≥ 100,000 /mm3 Serum creatinine≤ normal range\ 1.5x Aminotransferase/Alkaline phosphatase ≤normal range\ 2.5x Total...
- Female patients with childbearing potential should be using adequate contraceptive measures. Female patients must have evidence of non-child-bearing potential(Post-menopausal defined as aged more than 50 years and...
- Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment...
- Uncontrolled active interstitial lung disease
- Pathologically confirmed N3 disease
- Uncontrolled stage III-IV other malignancy
- Uncontrolled Hypertension, Congestive Heart failure with New York Heart Association(NYHA) ≥ 3, acute myocardial infarct history within 6 months before screening. 2nd- 3rd Atrio-Ventricular(AV) block or complete AV block
- Gastrointestinal diseases (e.g. Chron's disease, ulcerative colitis) or malabsorption syndrome that would impact on drug absorption
- Active infection requiring ongoing treatment(e.g. active Hepatitis B virus, Hepatitis C virus or Human immunodeficiency virus)
- History of hypersensitivity to active or inactive excipients of Lazertinib or drugs with a similar chemical structure.
- No ability to comply with protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- 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 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.