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Clinical Trials List

Protocol NumberCA209-331

2015-12-01 - 2016-12-23

Phase III

Terminated3

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects with Relapsed Small-cell Lung Cancer after Platinum-based Fist Line Chemotherapy

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yuh-Min Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Te-Chun Hsia Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Small-cell Lung Cancer

Objectives

Primary Objectives To compare the OS of nivolumab versus chemotherapy in subjects with relapsed SCLC after platinum-based, first-line chemotherapy. Secondary Objectives To compare the progression free survival (PFS) of nivolumab versus chemotherapy To compare the objective response rate (ORR) of nivolumab versus chemotherapy

Test Drug

Nivolumab

Active Ingredient

Nivolumab 10mg/ml

Dosage Form

IV Injection

Dosage

100mg

Endpoints

Overall Survial is the primary endpoint of the study.

Inclution Criteria

Adult men and women with histologically or cytologically confirmed SCLC that recurred or progressed after platinum-based, first-line chemotherapy or chemoradiation therapy. Subjects must have had at least 4 cycles of platinum-based, first-line chemotherapy for either limited or extensive stage disease or if less than 4 cycles, must have had a BOR of at least partial or complete response.

Exclusion Criteria

Key Exclusion Criteria:
Active symptomatic central nervous system metastases, documented carcinomatous meningitis, active, known or suspected autoimmune disease, and prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), topotecan, or amrubicin

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    480 participants

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