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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-25

Study Completion Date

2021-06-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

Nivolumab administered every two weeks

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Intravenous infusion administered over 30 minutes at 240 mg

Interventions

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Nivolumab

Intravenous infusion administered over 30 minutes at 240 mg

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo BMS-936558

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No