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

Launched by SUNG YONG LEE · Apr 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lazertinib to see if it can help patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have an EGFR mutation after they have undergone a specific type of cancer treatment known as chemoradiation therapy. The goal is to find out if Lazertinib can improve the time patients live without their cancer worsening, which is called progression-free survival. This study is important because, while other treatments have shown benefits, there is still a need for effective therapies for patients in this situation.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of non-squamous NSCLC that cannot be surgically removed. They should have received at least two cycles of platinum-based chemoradiation therapy and need to be within 1 to 42 days after finishing this treatment without any disease progression. Participants will be closely monitored and will need to provide written consent to take part in the study. The trial is currently recruiting participants, and it’s open to all genders. If you or someone you know fits these criteria, this trial could offer a new treatment option for managing their cancer.

Gender

ALL

Eligibility 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