To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC

This is an interventional supportive care trial for NSCLC Stage IV focused on measuring NSCLC, QoL, Fucoidan Read More

Inclusion Criteria:

• Male or female subjects must be ≥ 20 years of age, inclusive, at time of screening.
• Life expectancy > 12 weeks.
• Subject must have cytologically or histologically confirmed NSCLC. Subjects with mixed histology tumors will be eligible. If cytology is used for diagnosis, the sample must be unequivocally NSCLC.
• Subject has Stage III or IV NSCLC disease at the time of screening.
• Subject is not amenable to surgical resection or radiation with curative intent and have not received chemotherapy for their NSCLC, no matter it is new diagnosis or relapse.
• Subject is planned to receive triweekly platinum-based chemotherapy regimen prior to randomization. (Platinum dose for cisplatin is 51~80 mg/m2, or carboplatin at AUC 4~6)
• Subject must have at least 1 measurable tumor lesion, not previously irradiated, as defined by RECIST (version 1.1).
• Subject must have no history of brain metastases or evidence of CNS tumors at screening assessment..
• Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
• Subject must be able to take oral medication.

• Subject must have adequate bone marrow, renal and hepatic function as follows:

  • Absolute neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L);
  • Platelets ≥ 100,000/mm3 (100 × 109/L);
  • Hemoglobin ≥ 9.0 g/dL (5.6 mmol/L);
  • Serum creatinine concentration within the normal range (according to the standard value of each hospital);
  • Hepatic function: AST and ALT ≤ 2.5 times upper limit of normal unless liver metastases are present, then AST and ALT < 5.0 times upper limit of normal; bilirubin ≤ 1.5 times upper limit of normal (subjects with Gilbert's Syndrome may have a bilirubin ≤ 3.0 times upper limit of normal).
• Female and male patients of childbearing potential and at the risk of pregnancy must agree to use at least one of highly effective contraception method throughout the study.
• Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign inform consent.

Exclusion Criteria:

• Subject has a known hypersensitivity to Fucoidan, platinum compounds and all other drug component of current chemotherapy.
• Subject has peripheral neuropathy ≥ grade 2.
• Subject has a history of seizure within 12 months prior to study entry.
• Subject has received more or equal to third-line biomarker-targeted therapy.
• Subject has received herbal remedies for cancer treatment, non-prescription anti-cancer supplements for cancer treatment, or traditional Chinese medicine with an approved anti-cancer indication within 2 weeks prior to randomization.
• Subject is undergone or planned to receive curative radiation therapy prior to randomization and during study. (The palliative radiation therapy such as for bony lesions is allowed, but irradiate on target lesion will not be allowed.)

• Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:

  • Uncontrolled nausea/vomiting/diarrhea;
  • Active uncontrolled infection;
  • Symptomatic congestive heart failure;
  • Unstable angina pectoris or cardiac arrhythmia;
  • Psychiatric illness/social situation that would limit compliance with study requirements;
  • History of gross hemoptysis;
  • Any medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.
• Subject is pregnant or lactating.
• Subject participates in study using an investigational drug within 30 days prior to screening.