Actively Recruiting
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Led by Yonsei University · Updated on 2026-02-09
160
Participants Needed
1
Research Sites
329 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations.
CONDITIONS
Official Title
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older at the time of consent
- Histologically or cytologically confirmed completely resectable non-squamous non-small cell lung cancer (stages IB to IIIB, AJCC 8th edition)
- Complete surgical removal feasible as determined by a multidisciplinary team
- Presence of EGFR activating mutations (exon 19 deletion or L858R mutation)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function with specified lab value thresholds
- Life expectancy longer than 6 months
- Female participants must use effective contraception, not breastfeed, and have a negative pregnancy test before treatment; specific postmenopausal criteria apply
- Male participants without vasectomy must agree to use condoms and avoid sperm donation for specified periods after treatment
You will not qualify if you...
- Evidence of locally advanced or metastatic disease (Stage IIIC-IV)
- Known HIV positive status
- Severe or uncontrolled active infections, including chronic active hepatitis B or C except low viral load HBV with antiviral therapy
- Severe or uncontrolled systemic diseases such as uncontrolled hypertension or active bleeding
- History of solid organ transplantation
- History of interstitial lung disease requiring steroids or active ILD
- History of other malignancies within past 3 years except certain treated cancers
- Inability to take oral medication or absorption disorders that interfere with Lazertinib absorption
- Pregnant or lactating women
- Specific cardiac abnormalities including prolonged QT interval and significant rhythm disorders
- Known allergy to Lazertinib or related drugs
- Unlikely to comply with study procedures
- Participation in other interventional clinical trials except non-interventional ones
AI-Screening
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Trial Site Locations
Total: 1 location
1
Severance hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hye Ryun Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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