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Clinical Trials List

Protocol NumberSB8-G31-NSCLC

2016-01-01 - 2018-12-26

Phase III

Terminated5

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

SB8

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Samsung Bioepis co., Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Inn-Wen Chong Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 何明霖 Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Te-Chun Hsia Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏裕峰 Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Te-Chun Hsia 未分科

Co-Principal Investigator

Audit

None

Principal Investigator Inn-Wen Chong 未分科

Co-Principal Investigator

Audit

None

Principal Investigator Chien-Ying Liu Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Taiwan National PI

劉劍英

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Stop recruiting

Audit

None

Condition/Disease

NSCLC

Objectives

Best Objective Response Rate by 24 weeks [ Time Frame: 24 weeks from randomisation ] Any PR or CR prior to the 24th week will be marked as response

Test Drug

SB8

Active Ingredient

bevacizumab

Dosage Form

concentration for infusion
concentration for infusion

Dosage

100mg
400mg

Endpoints

Best Objective Response Rate by 24 weeks [ Time Frame: 24 weeks from randomisation ]
Any PR or CR prior to the 24th week will be marked as response

Inclution Criteria

Aged ≥ 18 years
ECOG performance status of 0-1
Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
At least one measurable lesion according to RECIST v1.1.
Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

Exclusion Criteria

Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
Sensitizing EGFR mutations or ALK rearrangements
Increased risk of bleeding determined by investigator based on radiographic / clinical findings
History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    678 participants