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Clinical Trials List

Protocol NumberCA209-227
NCT Number(ClinicalTrials.gov Identfier)NCT02477826
Completed

2015-11-01 - 2025-08-29

Phase III

Terminated5

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator kang-Yun LEE Division of General Internal Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Terminated

Audit

None

Principal Investigator Chong-Jen Yu Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Non-Small Cell Lung Cancer (NSCLC)

Objectives

Primary Objectives:  In subjects with previously untreated stage IV or recurrent PD-L1+ NSCLC:  To compare the overall survival of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy  To compare progression-free survival based on blinded independent central review (BICR) assessment, of nivolumab monotherapy and nivolumab in combination with Ipilimumab to platinum-doublet chemotherapy  In subjects with previously untreated stage IV or recurrent PD-L1- NSCLC:  To compare the overall survival of nivolumab in combination with ipilimumab to platinum-doublet chemotherapy  To compare progression-free survival based on BICR assessment, of nivolumab in combination with ipilimumab to platinum-doublet chemotherapy Secondary Objectives:  In subjects with previously untreated stage IV or recurrent PD-L1+ NSCLC:  To compare the objective response rate (ORR), based on BICR assessment, of nivolumab and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy  To estimate the OS and PFS hazard ratio comparing the treatment effect of nivolumab in combination with ipilimumab to nivolumab monotherapy  In subjects with previously untreated stage IV or recurrent PD-L1- NSCLC:  To compare the ORR, based on BICR assessment, of nivolumab in combination with ipilimumab to platinum-doublet chemotherapy  To estimate the OS and PFS hazard ratio comparing the treatment effect of nivolumab in combination with ipilimumab to nivolumab  To evaluate the proportion of treated patients, regardless of PD-L1 expression, exhibiting disease-related symptom improvement by 12 weeks as measured by the Lung Cancer Symptom Score (LCSS) in subjects receiving nivolumab monotherapy, nivolumab in combination with ipilimumab and in subjects receiving platinum doublet chemotherapy

Test Drug

Nivolumab

Active Ingredient

Nivolumab

Dosage Form

solution for injection

Dosage

10mg/mL；10mL/vial

Endpoints

Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: approximately 48 months ]
2. Progression-free Survival (PFS) as determined by blinded independent central review (BICR) [ Time Frame: approximately 40 months ]

Secondary Outcome Measures :
1. Objective response rate (ORR) [ Time Frame: Up to 48 months ]
ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer

2. Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects [ Time Frame: Up to 48 months ]
Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment

Inclution Criteria

Key Inclusion Criteria
 ECOG Performance Status of  1.
 Patients with histologically confirmed Stage IV or recurrent NSCLC (per the 7th International Association for
the Study of Lung Cancer classification squamous or nonsquamous histology, with no prior systemic anticancer
therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease.
 Measurable disease by CT or MRI per RECIST 1.1 criteria.

Exclusion Criteria

Key Exclusion Criteria
 Subjects with known EGFR mutations which are sensitive to available targeted inhibitor therapy.
 Subjects with known ALK translocations which are sensitive to available targeted inhibitor therapy.
 Subjects with untreated CNS metastases are excluded, even if asymptomatic.
 Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus,
hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not
requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are
permitted to enroll.
 Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone
equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical
steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of
active autoimmune disease.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    1980 participants

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