Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

• Status: Not yet recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myung-Ju Ahn
• Treatments: Lazertinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.

• Stage IIIC or IV by AJCC 8th edition

• Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)

• Age of 19 or more.

• Performance status of Eastern Cooperative Oncology Group 0 to 2.

• Expected minimum life expectancy of 12 weeks

• Adequate organ function.

• Available to provide the adequate tissue and blood for the genomic tests- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression.

• Agreed to perform re-biopsy at the timepoint of disease progression.

• At least two weeks after the chemotherapy

• Female subjects must either be of non-reproductive potential

• Subject willing and able to comply with the protocol

• Signed written informed consent

Exclusion Criteria:

• Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)

• Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)

• Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.

• Spinal cord compression, leptomeningeal carcinomatosis

• Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection

• Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week

• Any unresolved toxicities from prior therapy, greater than CTCAE grade 1

• Mean QT interval corrected for heart rate (QTc) ≥ 470 ms

• No measurable lesion

• Unable to swallow the product due to refractory nausea, vomiting or chornic gastrointestinal disease.