non-small cell lung cancer non-small cell lung cancer
Conditions
Interventions
Investigational new drug combination group: Complete resection surgery of non small cell lung carcinoma in combination with investigational new drug. The ONO-1101 is continuously administered intraven
Sponsors
Hida Yasuhiro
Sato Norihiro
Yamamoto Haruko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.NSCLC is suspected. 2.Radiologically diagnosed invasive lung tumor (cT1a or more in UICC 8th edition) 3.Lobectomy, bi-lobectomy or pneumonectomy is intended 4.Mediastinal lymph node dissection ND2a-1 or more is intended 5.No history of cancer (carcinoma in situ is excluded) treatment within 5 years. 6.Performance Status(PS)0 or 1
Exclusion criteria
Exclusion criteria: 1.Malignant tumors within 5years 2.Mental disorders 3.Patients on beta agonists or antagonists 4.Preoperative treatments for NSCLC 5.Active infections 6.Contraindication to use ONO-1011
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival [Time Frame: 2 years] Over all survival [Time Frame: Through study completion, an average of 3 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Efficacy/ Evaluation of treatments after relapse [Time Frame: Up to 4 years and 5 months] 2)Safety/ Evaluation of adverse event, blood pressure, 12-lead electrocardiography, clinical laboratory test [Time Frame: Up to 7 days after surgery] Evaluation of incidence of perioperative complication [Time Frame: Up to 30 days after surgery] | — |
Contacts
Public ContactNao Horie
Hokkaido University Hospital
Outcome results
None listed