Overview
This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
Description
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.
This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-nave and eligible for first-line treatment with an EGFR-TKI.
Eligibility
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the lung
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
- Treatment-nave for locally advanced or metastatic NSCLC
- WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
- At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period
Exclusion Criteria:
- Symptomatic and unstable brain metastases
- Leptomeningeal metastases
- Symptomatic spinal cord compression
- History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Any medical conditions requiring chronic continuous oxygen therapy
- History of any malignancy other than the disease under study within 3 years before randomization
- Any cardiovascular disease as follows:
- History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
- History of myocardial infarction or unstable angina within 24 weeks of randomization