The "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. However, in PACIFIC, no significant differences between durvalumab and placebo were observed in PFS. Unmet need remains in development of successful consolidation therapy following chemoradiation therapy in patients with EGFR-mutant stage III unresectable NSCLC. A recent "ADAURA" study showed that Osimertinib as an adjuvant therapy after surgery significantly prolonged disease-free survival in EGFR mutation-positive patients. Lazertinib, like Osimertinib, is a third-generation EGFR TKI agent and has shown excellent anticancer effects in preclinical studies and in early clinical settings. Based on these results of the 3rd generation EGFR TKI, Lazertinib, it is expected that there is a clinical benefit Lazertinib as consolidation therapy. This study aims to investigate the clinical benefits of Lazertinib (Trade name: LECLAZA Tab) consolidation therapy for patients with EGFR mutation-positive, unresectable stage III NSCLC after definitive platinum-based chemoradiation therapy.
This study is designed as a prospective, open-label, single-arm, multicenter, phase II, investigator-initiated trial. A total of 77 patients will participate in the study who have undergone definitive platinum-based concurrent chemoradiation therapy and have no disease progression. Patients are to be enrolled within 1 to 42 days after concurrent chemoradiation therapy and to be administrated with lazertinib 240mg oral once daily until disease progression, or unacceptable toxicity. Patients will visit every 8 weeks and perform CT/MRI tumor evaluation by investigator, and will be followed up for survival every 3 months by phone thereafter. Patients will be followed up till maximum of appropriately 4 years of which 3 years since the last patient enrollment must be.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Lazertinib 240mg (3 Tabs as Laclaza Tab 80mg) once daily in oral can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Kosin University Gospel Hospital
Busan, South Korea
RECRUITINGKeimyung University Dongsan Hospital
Daegu, South Korea
RECRUITINGKyungpook National University Medical Center
Daegu, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, South Korea
RECRUITINGChonnam National University Hospital Hwasun Hospital
Gwangju, South Korea
RECRUITINGInha University Hospital
Incheon, South Korea
RECRUITINGPusan National University Yangsan Hospital
Pusan, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGHanyang University Seoul Hospital
Seoul, South Korea
RECRUITINGKoera University Guro Hospital
Seoul, South Korea
RECRUITING...and 3 more locations
Progression free survival (PFS)
The time from the date of enrollment until the date of disease progression or death (by any cause in the absence of progression) Per RECIST 1.1 as assessed by Investigator.
Time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Overall survival (OS)
The time from the date of enrollment until the date of death
Time frame: Until death (up to maximum of approximately 4 years)
Objective response rate (ORR)
The number (%) of patient at least 1 visit response of Complete response (CR) or Partial response (PR). Per RECIST 1.1 as assessed by Investigator.
Time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Duration of response (DoR) Duration of response (DoR)
The time from the date of first documented response until the first date of documented progression (or death in the absence of disease progression) Per RECIST 1.1 as assessed by Investigator.
Time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Time to death or distant metastasis (TTDM)
The time from the date of enrollment until the first date of distant metastasis or death in the absence of distant metastasis. Per RECIST 1.1 as assessed by Investigator.
Time frame: Until death or distant metastasis (up to maximum of approximately 4 years)
Safety profile : Adverse Events according to CTCAE V5.0
Adverse events, Serious adverse events or other significant safety findings
Time frame: every visit (up to maximum of approximately 4 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.