Status:
RECRUITING
A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy
Lead Sponsor:
Sung Yong Lee
Collaborating Sponsors:
Yuhan Corporation
Conditions:
Non-small Cell Lung Cancer Stage III
EGFR Positive Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ch...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia
- History of other primary malignancy
- Mixed small cell and NSCLC histology
- Prior treatment with EGFR-TKI Therapy
- Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation
- Current history of CTCAE grade 2 or higher pneumonia prior to chemoradiation therapy
- Patients with severe hypersensitivity to active ingredient or excipient of the investigational medicinal product
- Pregnant or breastfeeding patients
- Patients who do not agree to contraception with medically acceptable method for at least 6 months after the end of study intervention treatment
- Patients who participated in clinical trials within 4 weeks before participating in this study
- Judgment by the investigator that the patient is unsuitable to participate in this study
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2026
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05338619
Start Date
June 30 2022
End Date
March 2 2026
Last Update
September 1 2023
Active Locations (13)
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1
Kosin University Gospel Hospital
Busan, South Korea
2
Keimyung University Dongsan Hospital
Daegu, South Korea
3
Kyungpook National University Medical Center
Daegu, South Korea
4
Chungnam National University Hospital
Daejeon, South Korea