Mushroom extract BLEX 404 joins chemo in new lung cancer trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged 20 - 70 years old at the time of signing the ICF. 2. Naïve patients with histologically or pathologically diagnosed with Advanced Inoperable or Metastatic non-small cell lung cancer and intended for first line treatment. 3. Patients with histologically or pathologically diagnosed with nonsquamous non-small cell lung cancer who are: EGFR wild-type (no EGFR gene mutation) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. 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). 6. 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). 7. Adequate renal function: calculated creatinine clearance ≥ 60 mL/minute according to the Cockcroft and Gault formula. 8. At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 9. 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. 10. Planning to receive Pemetrexed + Cisplatin Therapy. 11. Willing and able to comply with all aspects of the treatment protocol. 12. Provide written informed consent. Exclusion Criteria: 1. Women who are pregnant or breast feeding. 2. Patients with brain metastasis but asymptomatic need not be excluded. 3. Patients with autoimmune disease that requires systemic steroids or immunosuppression agents. 4. Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent. 5. 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. 6. Known history of human immunodeficiency virus (HIV) infection. 7. Existing anticancer treatment-related toxicities of Grades ≥ 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v5.0). 8. Patients with Grade \> 2 neuropathy. 9. Patients with an active infection requiring systemic therapy. 10. 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. 11. 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. 12. 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). 13. Ascertained hypersensitivity to investigational product, Pemetrexed or any of the excipients used in the study. 14. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment. 15. 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.