Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy

Korábbi kezelés

• Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
• Patients with following treatment prior to Pemetrexed + Cisplatin Therapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior received taxanes in adjuvant therapy within 12 months; prior received polysaccharide-based drugs within 6 months; radiation therapy within 28 days (90 days for bone marrow exposure 20%); hormonal therapy within 28 days.
• History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the patient's ability to safely complete the study.
• Ascertained hypersensitivity to investigational product, Pemetrexed or any of the excipients used in the study.

Más betegség

• Patients with autoimmune disease that requires systemic steroids or immunosuppression agents.
• Known history of human immunodeficiency virus (HIV) infection.
• Patients with an active infection requiring systemic therapy.
• Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.

Laborértékek

• Patients with active liver disease, such as hepatitis C virus (HCV) carriers, and/or those with active viral disease which is defined as hepatitis B virus (HBV)carriers with HBV DNA > 2,000 IU/ml plus AST and ALT > 3-fold ULN, other liver viral disease or autoimmune liver disease.
• Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval] of a QTc interval >450 ms. (referred to Subject enrollment 2.1.1 E14 clinical Evaluation of QT/QTC).

Egyéb

• Women who are pregnant or breast feeding.
• Patients with brain metastasis but asymptomatic need not be excluded.
• Existing anticancer treatment-related toxicities of Grades ≥ 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v5.0).
• Patients with Grade > 2 neuropathy.
• Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.

• Patients aged 20 - 70 years old at the time of signing the ICF.
• Naïve patients with histologically or pathologically diagnosed with Advanced Inoperable or Metastatic non-small cell lung cancer and intended for first line treatment.
• Patients with histologically or pathologically diagnosed with nonsquamous non-small cell lung cancer who are: EGFR wild-type (no EGFR gene mutation)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Adequate hematologic function defined as: absolute neutrophil count (ANC)
  • ≥ 2,000/μL; platelets count ≥ 100,000/μL; hemoglobin must be ≥10 g/dL (can be corrected by growth factor or transfusion).
• Adequate hepatic function defined as: serum total bilirubin ≤ 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3-fold ULN (5- fold ULN if liver metastasis is observed).
• Adequate renal function: calculated creatinine clearance ≥ 60 mL/minute according to the Cockcroft and Gault formula.
• At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Women must be either of non-childbearing potential, or women with child- bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.
• Planning to receive Pemetrexed + Cisplatin Therapy.
• Willing and able to comply with all aspects of the treatment protocol.
• Provide written informed consent.