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Phase 1 Study of Ipilimumab (BMS-734016) in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Phase 1 Study of Ipilimumab (BMS-734016) in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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

- Life expectancy of at least 3 months

- Eastern Cooperative Oncology Group performance 0-1

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose of ipilimumab in combination with paclitaxel and carboplatin

Outcome Time Frame:

From Day 1 at 3rd cycle to Day 21 at 4th cycle

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA184-113

NCT ID:

NCT01165216

Start Date:

September 2010

Completion Date:

July 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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