non-small cell lung cancer
Conditions
Interventions
Patients will receive intravenous nivolumab (240 mg every 2 weeks or 480 mg every 4 weeks) and oral administration of TM5614 (120 mg every day, in the absence of serious adverse events during the firs
Sponsors
Masuda Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age of >=18 years at the time of informed consent (2) Provision of written informed consent (3) Histologically confirmed stage III with no indication for curative surgery, radiotherapy, stage IV, or recurrent NSCLC (4) No sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements in patients with non-squamous carcinoma (5) No or unknown ROS-1 rearrangement, BRAF (V600E) gene mutation, MET exon 14 skipping mutation, RET rearrangement, or NTRK rearrangement. (6) Disease progression during or after the most recent treatment and history of treatment - Platinum doublet chemotherapy - Immune checkpoint inhibitors (e.g. nivolumab, pembrolizumab, atezolizumab, nivolumab, and ipilimumab) - Chemotherapy (e.g. pemetrexed, docetaxel, nab-paclitaxel, S-1) (7) Measurable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST) Ver.1.1 (8) Eastern Cooperative Oncology Group performance status of 0-1 (9) Estimated life expectancy of >=90 days (10) Adequate organ function within 7 days prior to registration. The laboratory values must not have received granulocyte colony stimulating factor (G-CSF) administration or blood transfusion within 14 days prior to the test. - Neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin is 8.5 g/dL or higher - AST and ALT less than or equal to 3 times the upper limit of the reference value of the medical institution performing the procedure. If the patient has liver metastasis, AST and ALT are 5 times or less than the upper limit of the reference value of the implementing medical institution. - Total bilirubin is 2 times or less than the upper limit of the reference value at the institution. - Creatinine is 1.5 mg/dL or less, or creatinine clearance is 45 mL/min or more as measured or estimated by Cockcroft/Gault formula. - SpO2 greater than 90% (room air)
Exclusion criteria
Exclusion criteria: (1) Active autoimmune disease that has required systemic treatment using corticosteroids or other immunosuppressive medication. (2) History of serious immune-related adverse events caused by anti-PD-1/anti-PD-L1 antibodies. (3) Patients receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs exceeding 10 mg/day of prednisolone equivalent. (4) Multiple cancers. (5) Central nervous system metastases (symptomatic or requiring treatment). (6) Carcinomatous meningitis. (7) Evidence of interstitial pneumonia , Pulmonary fibrosis , Radiation pneumonitis. (8) Uncontrollable pleural effusion, ascites, or pericardial fluid. (9) Patients with stable and uncontrolled tumor-related pain. (10) Patients who have received external-beam or whole-brain irradiation of metastases within 14 days prior to enrollment. (11) Patients with bleeding tendency. (12) Patients with systemic infections requiring treatment. (13) Patients with uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival - Overall survival - Disease control rate - Duration of response - Adverse event rate | — |
Contacts
Public ContactTakeshi Masuda
Hiroshima University Hospital
Outcome results
None listed