Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Ipilimumab,Paclitaxel,Carboplatin
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for
Sponsors
Bristol-Myers K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically documented NSCLC who present with stage IIIB without indications for definitive radiotherapy or stage IV or recurrent - No prior chemotherapy, hormonal therapy, immunotherapy and targeted therapy containing regimens for the treatment of NSCLC
Exclusion criteria
Exclusion criteria: - Symptomatic central nervous system (CNS) metastasis, or active CNS metastasis requiring medication. - Malignant body cavity fluid (e.g. pleural effusion, cardiac effusion, ascites) that is recurrent despite appropriate supportive care. - Autoimmune disease: subjects with a documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressant treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose of ipilimumab in combination with paclitaxel and carboplatin [ Time Frame: From Day 1 at 3rd cycle to Day 21 at 4th cycle ] [ Designated as safety issue: Yes ] Same as current | — |
Secondary
| Measure | Time frame |
|---|---|
| - Plasma PK: Summary stats tabulated for PK parameters (Cmax, AUC(0-21d), Tmax, & T-HALF) by ipilimumab dose. - Tumor response: Individual tumor Best Overall Responses by RECIST criteria version 1.1 will be listed for each dose level Same as current | — |
Outcome results
None listed