Using Lazertinib for Patients with Advanced Lung Cancer After Chemoradiation
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)
PHASE2 · Korea University Guro Hospital · NCT05338619
This study is testing if the medication Lazertinib can help people with advanced lung cancer live longer without their cancer getting worse after they finish chemotherapy and radiation.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Korea University Guro Hospital (other) |
| Drugs / interventions | radiation, durvalumab, Osimertinib, Lazertinib |
| Locations | 13 sites (Busan and 12 other locations) |
| Trial ID | NCT05338619 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Lazertinib as a consolidation therapy for patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have completed definitive platinum-based chemoradiation therapy without disease progression. It is a phase II, open-label, single-arm trial involving 77 participants who will receive Lazertinib orally once daily for up to four years, with regular follow-ups for tumor evaluation and survival assessment. The aim is to determine if Lazertinib can improve progression-free survival in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced, unresectable stage III NSCLC who have not experienced disease progression after chemoradiation.
Not a fit: Patients with a history of interstitial lung disease, prior EGFR-TKI therapy, or unresolved toxicity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly prolong progression-free survival for patients with advanced EGFR-mutant lung cancer.
How similar studies have performed: Previous studies have shown promising results with other EGFR-TKIs like Osimertinib, indicating potential for success with Lazertinib as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years and older 2. 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 3. ECOG PS 0,1 4. Expected life expectancy of 6 months and more 5. 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 6. Patients must not have had disease progression during or following CCRT 7. Patients with adequate organ and bone marrow function 8. Patients who give in written consent voluntarily to participate in this study Exclusion Criteria: 1. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia 2. History of other primary malignancy 3. Mixed small cell and NSCLC histology 4. Prior treatment with EGFR-TKI Therapy 5. Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation 6. Current history of CTCAE grade 2 or higher pneumonia prior to chemoradiation therapy 7. Patients with severe hypersensitivity to active ingredient or excipient of the investigational medicinal product 8. Pregnant or breastfeeding patients 9. Patients who do not agree to contraception with medically acceptable method for at least 6 months after the end of study intervention treatment 10. Patients who participated in clinical trials within 4 weeks before participating in this study 11. Judgment by the investigator that the patient is unsuitable to participate in this study
Where this trial is running
Busan and 12 other locations
- Kosin University Gospel Hospital — Busan, Korea, Republic of (RECRUITING)
- Keimyung University Dongsan Hospital — Daegu, Korea, Republic of (RECRUITING)
- Kyungpook National University Medical Center — Daegu, Korea, Republic of (RECRUITING)
- Chungnam National University Hospital — Daejeon, Korea, Republic of (RECRUITING)
- Chonnam National University Hospital Hwasun Hospital — Gwangju, Korea, Republic of (RECRUITING)
- Inha University Hospital — Incheon, Korea, Republic of (RECRUITING)
- Pusan National University Yangsan Hospital — Pusan, Korea, Republic of (RECRUITING)
- Asan Medical Center — Seoul, Korea, Republic of (RECRUITING)
- Hanyang University Seoul Hospital — Seoul, Korea, Republic of (RECRUITING)
- Koera University Guro Hospital — Seoul, Korea, Republic of (RECRUITING)
- Korea University Anam Hospital — Seoul, Korea, Republic of (RECRUITING)
- Kyung Hee University Hospital — Seoul, Korea, Republic of (RECRUITING)
- Yonsei University Health System, Severance Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Sung Yong Lee, MD, PhD — Korea University Guro Hospital
- Study coordinator: Sung Yong Lee
- Email: syl0801@korea.ac.kr
- Phone: 82 2 2626 1914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, NSCLC, Non-squamous cell carcinoma, EGFR, EGFR-TKI, Lazertinib