Advanced non-squamous non-small cell lung cancer (Stage IIIB/IV or postoperative recurrent)
Conditions
Interventions
Dose of salazosulfapyridine of 1.5-7.5g per day (t.i.d), one (or two, or three, or four, or five) 500mg tablet each time. Until PD (include criteria for discontinuing) or 365 days from start of admini
Sponsors
Kyushu University Hospital
National Hospital Organization Kyushu Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical stage III or IV or postoperative recurrent non-squamous non-small cell lung cancer that has not been treated with chemotherapy a) and cannot be treated with curative radiotherapy. a) Neither EGFR tyrosine kinase inhibitors for EGFR mutation-positive patients nor ALK tyrosine kinase inhibitors in ALK fusion gene-positive patients are included in prior treatments. b) In postoperative recurrent disease, at least 24 weeks have passed from the last dose of postoperative adjuvant chemotherapy, if applicable, and the postoperative adjuvant chemotherapy must not contain cisplatin or pemetrexed. 2. Aged 20 years or older at the time of informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 4. All of the following criteria are met based on the latest data obtained within 14 days before enrollment: 1) Neutrophil count >= 1,500/mm^3 2) Hemoglobin >= 9.0 g/dL 3) Platelet count >= 10*104/mm^3 4) Total bilirubin <= 1.5 mg/dL 5) AST (GOT) <= 100 6) ALT (GPT) <= 100 7) SpO2 >= 92% in indoor air. Patients with SpO2 < 92% are eligible if PaO2 is 60 torr or more. 8) Creatinine clearance >= 60 mL/min Patients with estimated creatinine clearance < 60 mL/min are eligible if creatinine clearance is actually determined to be 60 mL/min or more using a 24-hour specimen of urine. 5. No symptomatic brain metastasis or spinal metastasis requiring irradiation or surgical procedure. 6. No Grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites Patients with a history of pleural effusion are eligible if there is no evidence of Grade 3 pleural effusion at 2 weeks after discontinuation of drainage following intrapleural infusion of antimicrobials or OK432. 7. No palliative radiotherapy for metastatic lesion(s) within 14 days before enrollment. 8. Able to swallow oral medications. 9. Have given written consent to participate in the study after receiving detailed explanation of the study.
Exclusion criteria
Exclusion criteria: 1. Patients with an infection requiring systemic treatment. 2. Patients who cannot be in the hospital throughout the first DLT evaluation period of the cisplatin-pemetrexed-salazosulfapyridine combination therapy. 3. Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study. 4. Patients treated with an immune suppressor (oral or intravenous). 5. Patients with unstable angina (new-onset angina or exacerbation of angina within the last 3 weeks) or poorly controlled hypertension or diabetes mellitus. 6. Positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody. 7. Evidence of interstitial pneumonia or pulmonary fibrosis in chest CT scan 8. History of hypersensitivity to sulfa drugs or salicylic acid preparations 9. Patients with ulcerative colitis or treatment with salazosulfapyridine or 5-ASA derivatives. 10. Pregnant or lactating females (including the females who canceled the breastfeeding before participating to the study and have possibility to re-start the nursing). Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before registration. 11. Nonsterilized males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol (section 6.4., 5) ). 12. Patients who have participated to other clinical studies within 12 weeks before the consent obtaining. However, the drug information that has been administered in the clinical trial has become clear, so that the investigator (sub-investigator) except if that there is no impact on the participation of the clinical trial. 13. Any other condition, which in the opinion of the investigator or sub-investigator would preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with dose-limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with at least 1 adverse event Percentage of responders Progression-free survival (PFS) Pharmacokinetics | — |
Countries
Japan
Outcome results
None listed