Comprehensive study for the potential blood-based biomarkers for NSCLC patients treated with lazertinib

Comprehensive study for the potential blood-based biomarkers for EGFR-mutant NSCLC patients treated with lazertinib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008254

Enrollment

100

Registered

2023-03-06

Start date

2023-05-10

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : For biomarker analysis, blood is collected before Lazertinib administration, at the time of the first tumor response evaluation after Lazertinib administration, and at the time when disease pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A person who has given written consent to participate in this study 2) Adult men and women over 19 years of age 3) Patients with histologically or cytologically confirmed non-small cell lung cancer 4) Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive after treatment failure with 1st or 2nd generation EGFR-TKIs 5) Patients with ECOG PS of 0~2

Exclusion criteria

Exclusion criteria: 1) Patients who have received systemic steroid or immunosuppressant treatment within 2 weeks prior to Lazertinib administration 2) Patients who received antibiotic treatment within 2 weeks prior to Lazertinib administration 3) Patients currently being treated for connective tissue disease or inflammatory bowel disease 4) Patients confirmed as positive for ALK fusion 5) Patients with confirmed malignant tumors prior to participating in this study However, registration is possible in the following cases, but registration is not possible if the patient is accompanied by a malignant tumor requiring current treatment. - Cases confirmed as malignant tumors (including lung cancer) but in remission for more than 5 years after completion of treatment -Efficiently treated non-melanoma skin cancer, cervical carcinoma in situ, mammary ductal carcinoma in situ, localized prostate cancer, and thyroid cancer treated for curative purposes can be registered.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival, PFS	—

Secondary

Measure	Time frame
Objective Response Rate, ORR;Duration of Response, DoR;Overall Survival, OS;PIV(pan-immune-inflammation value), NLR(Neutrophil-Lymphocyte Ratio), PLR(platelet-lymphocyte ratio), SIRI(Systemic Inflammation Response Index)	—

Countries

Korea, Republic of

Contacts

Public ContactSeung Hyeun Lee

Kyung Hee University Hospital

humanmd04@hanmail.net+82-2-958-8511

Outcome results