A Phase II, Multicenter Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR Mutation Positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Chemoradiation Therapy (PLATINUM Trial)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years and older

• Histologically and cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) non-squamous cell carcinoma who present with locally advanced, unresectable, Stage III disease

• ECOG PS 0,1

• Expected life expectancy of 6 months and more

• Patients who have received at least 2 cycles of definitive platinum-based concurrent chemoradiation therapy (CCRT) and who must be within 1 to 42 days after completion of radiation therapy

• Patients must not have had disease progression during or following CCRT

• Patients with adequate organ and bone marrow function

• Patients who give in written consent voluntarily to participate in this study

Locations
Other Locations
Republic of Korea
Kosin University Gospel Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Kyungpook National University Medical Center
RECRUITING
Daegu
Chungnam National University Hospital
RECRUITING
Daejeon
Chonnam National University Hospital Hwasun Hospital
RECRUITING
Gwangju
Inha University Hospital
RECRUITING
Incheon
Pusan National University Yangsan Hospital
RECRUITING
Pusan
Asan Medical Center
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Koera University Guro Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Yonsei University Health System, Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Sung Yong Lee
syl0801@korea.ac.kr
82 2 2626 1914
Backup
Youngsun Cho
choyoungsun@procuratio.kr
82 70 4820 0249
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2026-03-02
Participants
Target number of participants: 77
Treatments
Experimental: Lazertinib
Lazertinib 240mg, oral, QD
Sponsors
Collaborators: Yuhan Corporation
Leads: Sung Yong Lee

This content was sourced from clinicaltrials.gov

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