A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia (CheckMate870)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Lung Cancer

Non-Small Cell Lung Cancer

Treatments

Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03195491

CA209-870

Details and patient eligibility

About

The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
1 to 2 prior systemic therapies
Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment

Exclusion Criteria:

Women with a positive pregnancy test at enrollment or prior to administration of study medication
Participants with active central nervous system metastases
Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
Participants with carcinomatous meningitis

Other protocol defined inclusion/exclusion criteria could apply