Clinical Trials Logo

Clinical Trial Summary

This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment. The objective of this study is as follows. - Primary objective : intracranial objective response rate (iORR) with RECIST 1.1 - Secondary objectives : intracranial progression free survival(iPFS), Intracranial objective response rate in T790M negative, isolated CNS progression patient group, overall Objective Rsponse Rate(ORR), duration of response(DoR), disease control rate(DCR), treatment failure pattern): intracranial progression or extracranial progression or both, salvage intracranial treatment rate, safety and tolerability


Clinical Trial Description

Patients who eligible the inclusion/exclusion criteria should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible on an empty stomach before meals. One cycle of treatment is defined as 42 days of continuous administration, and the tumor response by RECIST 1.1 will be evaluated every 1 cycle for the 1st, 2nd, 3rd, and 4th evaluation, and every 2 cycles from the 5th evaluation thereafter. . If the investigator decides to reduce the dose due to an adverse drug reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib. Efficacy and safety will be evaluated by administering lazertinib 240 mg to patients with measurable brain metastasis or newly confirmed metastatic non-small cell lung cancer after failure of treatment with gefitinib, erlotinib, or afatinib after EGFR mutation is confirmed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05326425
Study type Interventional
Source Seoul St. Mary's Hospital
Contact Jin Hyoung Kang
Phone 82-2-2258-6043
Email oncologykang@naver.com
Status Recruiting
Phase Phase 2
Start date June 23, 2021
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03357094 - Pulmonary Ventilation/Perfusion Imaging for the Prediction of Postoperative Residual Pulmonary Function N/A
Recruiting NCT05543954 - 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients Early Phase 1
Completed NCT01114958 - Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases Phase 1
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Active, not recruiting NCT02514512 - Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking N/A
Completed NCT02531737 - Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer Phase 2
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Active, not recruiting NCT02284633 - Blood Sample Monitoring of Patients With EGFR Mutated Lung Cancer
Completed NCT02106143 - RejuvenAirâ„¢ System Lobectomy Safety and Histology Study N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Enrolling by invitation NCT01687647 - Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure Phase 3
Terminated NCT00356525 - Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor Phase 2
Completed NCT00351962 - Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours N/A
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Withdrawn NCT00090701 - A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Recruiting NCT01789229 - Establishment of a Tumor Bank for Tissue Samples