Non-small cell lung cancer Non-Small Cell Lung Cancer
Conditions
Interventions
RAM: 10 mg/kg, day 1 of every 3-week cycle
DTX: 60 mg/m2, day 1 of every 3-week cycle
Sponsors
Morise Masahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed NSCLC. 2. Patients with stage III NSCLC without indication for radical thoracic irradiation and stage IV/recurrent NSCLC. 3. Patients who have had disease progression during or after first-line platinum-based chemotherapy combined with ICI regimen with or without maintenance therapy for advanced/metastatic disease. * Driver gene-targeted therapies are allowed in patients with driver gene abnormality, such as EGFR, ALK, ROS1, etc. 4. Patients aged 20 years or older. 5. Patients with an ECOG PS of 0 or 1. 6. Patients who have measurable disease at the time of registration documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines, version 1.1. 7. Patients who have resolution to Grade 14 days after drainage are allowed). 10. Patients with adequate organ function, defined as follows: * Patients with adequate hepatic function as defined by a total bilirubin = 40 ml/min (per the Cockcroft-Gault formula or equivalent and/or 24-h urine collection). * Absolute neutrophil count (ANC) >= 1.5 x 103/micro liter, hemoglobin >=10.0 g/dl, and platelets >= 100 x 103/micro liter. * The patient must have adequate coagulation function, as defined by the international normalized ratio (INR) = 2 +, then a 24-h urine must be collected and must demonstrate = 3 months. 16. Prior radiation therapy is allowed if: * In the case of chest radiotherapy, at least 90 days has elapsed from the completion of radiation treatment prior to reg
Exclusion criteria
Exclusion criteria: 1. The patient's tumor wholly or partially contains small cell lung cancer. 2. The patient has undergone major surgery within 28 days prior to registration or subcutaneous venous access device placement within 7 days prior to registration. Furthermore, any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded. 3. The patient has a scheduled major surgery during the course of the trial. 4. The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy. * The last dose of any anticancer therapy must be at least 28 days prior to registration. * The last dose of bevacizumab must be at least 28 days prior to registration. 5. The patient has radiologically documented evidence of major blood vessel invasion or encasement by cancer. 6. The patient has radiographic evidence of intratumor cavitation, regardless of tumor histology. 7. The patients have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or other severe thromboembolic events (Venous port thrombosis, catheter thrombosis, or superficial vein thrombosis are excluded.) within 3 months prior to registration. 8. Patients with a history of hemoptysis within 2 months prior to registration. 9. Patients with a medication history of antiplatelet (aspirin 325 mg/day or more, clopidogrel, ticlopidine, dipyridamole) within 14 days, anti-vitamin K, or anticoagulation therapy. 10. The patient has clinically relevant congestive heart failure (CHF) (NYHA II-IV) or cardiac arrhythmia poorly controlled by medications. 11. The patient has experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to registration. 12. The patient has uncontrolled arterial hypertension >= 150/ >=90 mm Hg despite standard medical management. 13. The patient has had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to registration. 14. The patient has significant bleeding disorders or vasculitis or has experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to registration. 15. History of GI perforation and/or fistulae within 6 months prior to registration. 16. The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 17. The patient has a CTCAE Grade 2 or more peripheral neuropathy. 18. The patient has a serious illness or medical condition(s) including: * Known positive test results for human immunodeficiency virus (HIV), hepatitis B*, or hepatitis C antibodies (HCVAb). * Have evidence of or test positive for hepatitis B. A positive test for hepatitis B is defined as follows: - positive for hepatitis B surface antigen (HBsAg+) OR - positive for anti-hepatitis B core antibody (HBcAb+) and positive for hepatitis B deoxyribonucleic acid (HBV DNA) OR - positive for anti-hepatitis B surface antibody (HBsAb+) and positive for HBV DNA * Acquired immunodeficiency syndrome (AIDS)-related illness. * Active or uncontrolled clinically serious infection. * Previous or concurrent malignancy, except for basal or squamous cell skin cancer and/or in situ carcinoma of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, PFS, OS | — |
Contacts
Public ContactReiko Matsuzawa
Nagoya University Hospital
Outcome results
None listed