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Clinical Trials List

Protocol NumberONO-4538-52
NCT Number(ClinicalTrials.gov Identfier)NCT03117049

2017-06-26 - 2024-05-31

Phase III

Terminated10

ICD-10C34

Malignant neoplasm of bronchus and lung

ONO-4538 Phase 3 study A Multicenter, Randomized, Double-Blind Trial in Subjects with Non-Squamous Non-Small Cell Lung Cancer

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    ONO Pharmaceutical Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

7 Completed

Audit

None

Principal Investigator 蕭聖諺 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 林慶雄 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 方昱宏 Division of Thoracic Medicine
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

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

Co-Principal Investigator

Audit

None

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

12 Completed

Audit

None

Principal Investigator Jen-Yu Hung 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

CRO

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

NSCLC

Objectives

In a multicenter, randomized, double-blind trial, compared ONO- in subjects who had never received chemotherapy and had stage IIIB/IV or recurrent non-squamous non-small cell lung cancer that were not suitable for radical radiotherapy. The efficacy and safety of 4538 combined carboplatin, paclitaxel and bevacizumab therapy (ONO-4538 group) and placebo combined with carboplatin, paclitaxel and bevacizumab therapy (placebo group)

Test Drug

Nivolumab (ONO-4538)

Active Ingredient

Nivolumab (ONO-4538)

Dosage Form

Solution for Injection

Dosage

100 mg/Vial (10 mg/mL)

Endpoints

1. Efficacy indicators-main indicators
a. Exacerbation-free survival (assessed by the Independent Radiological Evaluation Committee [IRRC])
2. Efficacy indicators-secondary indicators
a. Overall survival
b. No deterioration survival period (assessed by the trial host of the trial hospital)
c. Objective response rate (evaluated by the IRRC and the trial host of the trial hospital)
d. Disease control rate (assessed by the IRRC and the trial host of the trial hospital)
e. Duration of response (assessed by IRRC)
f. Time until a reaction occurs (assessed by IRRC)
g. The best overall response (evaluated by the IRRC and the trial host of the trial hospital)
h. The percentage of maximum change in the total diameter of the target lesion (assessed by IRRC)

Inclution Criteria


1. The subject has non-squamous non-small cell lung cancer confirmed by histological or cytological examination.
2. According to the UICC-TNM classification (7th edition), the subject has a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer that is not suitable for radical radiotherapy, and has not received systemic anti-cancer therapy .
3. The subject has at least one measurable lesion determined by the imaging tumor assessment according to the RECIST 1.1 standard.
4. The subject can provide tumor tissue samples.
5. ECOG physical status is 0 or 1.

Exclusion Criteria


1. The subject has known EGFR mutations, including exon 19 deletion mutations and exon 21 (L858R) substitution mutations.
2. The subject has a known translocation of ALK.
3. Have a history or complications of severe allergic reactions to antibody preparations or platinum-containing compounds.
4. The subject has an autoimmune disease, or a known chronic or recurrent autoimmune disease.
5. The subject has a variety of cancers.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    530 participants

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