Inclusion Criteria:

• Pathological and radiographic documented stage IIIB/IV NSCLC (squamous, adenocarcinoma, bronchioloalveolar, large cell, undifferentiated or not otherwise specified non-small cell carcinoma) diagnosed less than two months prior to randomization. Recommendations for classifying regional lymph node stations for lung cancer staging, adapted by the American Joint Committee on Cancer and the Union Internationale Contre le Cancer, will be used (Mountain).
• Patients must have measurable or non-measurable disease as defined in Response Evaluation Criteria in Solid Tumors (RECIST). The baseline measurements/evaluations must be obtained within 4 weeks prior to randomization.
• Patients must have ECOG performance status of 0-1 and life expectancy >3 months.
• Patients must be willing to receive chemotherapy after having had explained to them the benefits and risks of being treated with an Food and Drug Administration (FDA)-approved standard chemotherapy regimen (study 1) and after being told about a separate study for patients who refuse this standard chemotherapy (study 2).
• Patients must never have been diagnosed with any malignancy other than the current NSCLC, except for non-metastatic non-melanoma skin cancer, or cancer in situ of the cervix.
• Patients must be >18 years of age.
• Patients must demonstrate the ability and willingness to eat solid food and SV/placebo.
• Patients must demonstrate the ability and willingness to give informed consent.
• Patients must demonstrate the ability and willingness to follow the study requirements.

Exclusion Criteria:

• Laboratory criteria for exclusion within 14 days prior to randomization.

  • Liver function: bilirubin > 1.5x upper limit of normal (ULN) and SGOT (AST) > 2.5x ULN.
  • Renal function: Serum creatinine >1.5x ULN
  • Bone marrow function: white blood cell (WBC) < 4,000/µl; platelet count < 100,000 mm3; neutrophil count < 1,500/mm3.
  • Hemoglobin <9 gm/dl for males; < 8.5 gm/dl for females.
• Unexplained temperature > 38.5° C for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.
• Prior chemotherapy within 5 years and concurrent chemotherapy other than the chemotherapy permitted in this study.
• Prior radiation to the area of measurable or active tumor.
• Concurrent hormonal therapy, except for thyroid replacement therapy or glucocorticoids that are necessary for concurrent radiotherapy, adrenal failure, or septic shock. Glucocorticoids for anti-emetic prophylaxis and therapy should only be used as a last resort.
• Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication. Investigators should exercise caution when including patients taking other medications known to affect the conductive system e.g. beta blockers, calcium channel blockers, digoxin or other anti-arrhythmic drugs.
• Evidence of clinically significant neuropathy (> Grade 1) by physical exam.
• Patients must not be pregnant or breast-feeding. Female patients of child-bearing potential must have a negative pregnancy test performed within 72 hours prior to randomization. Women of child-bearing potential must agree not to become pregnant while participating in the study.
• Active acute infection, except for Herpes viruses (cytomegalovirus [CMV], Epstein Barr virus [EBV], herpes zoster virus [HZV], herpes simplex virus 1 [HSV 1]).
• A serious underlying medical condition other than NSCLC such that life expectancy is less than 2 years.
• Psychiatric illness that may affect the patient's compliance with the treatment.
• Current use of illicit drugs, glucocorticoids other than those necessary for concurrent radiotherapy, adrenal failure or septic shock, or other immune-suppressing or immune-modulating drugs. Glucocorticoids for anti-emetic prophylaxis and therapy should only be used as a last resort.
• A known allergy to one or more components of SV, namely soy beans, mushrooms, mung beans, red dates, scallion, garlic, lentil beans, leek, hawthorn fruit, onions, ginseng, angelica root, Chinese licorice, dandelion root, Senegal root, ginger, olives, sesame seed and parsley.