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Trial record 1 of 1 for:    NCT03117049
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Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

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ClinicalTrials.gov Identifier: NCT03117049
Recruitment Status : Active, not recruiting
First Posted : April 17, 2017
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date October 26, 2020
Actual Study Start Date  ICMJE June 13, 2017
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
Progression Free Survival (PFS) as assessed by the Independent Radiology Review Committee (IRRC) [ Time Frame: Up to approximately 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • Overall survival (OS) [ Time Frame: At least 3 years ]
  • PFS (as assessed by the study site's investigator) [ Time Frame: Up to approximately 3 years ]
  • Objective response rate (ORR [as assessed by the IRRC and study site's investigator]) [ Time Frame: Up to approximately 3 years ]
  • Disease control rate (DCR [as assessed by the IRRC and study site's investigator]) [ Time Frame: Up to approximately 3 years ]
  • Duration of response (DOR [as assessed by the IRRC]) [ Time Frame: Up to approximately 3 years ]
  • Time to response (TTR [as assessed by the IRRC]) [ Time Frame: Up to approximately 3 years ]
  • Best overall response (BOR [as assessed by the IRRC and study site's investigator]) [ Time Frame: Up to approximately 3 years ]
  • Maximum percentage of change in the sum of diameters of target lesions (as assessed by the IRRC) [ Time Frame: Up to approximately 3 years ]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Up to 100 days from last dose ]
  • Patient reported outcome (PRO) [ Time Frame: Up to approximately 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Brief Summary The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: ONO-4538
    360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
  • Drug: Carboplatin
    Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
  • Drug: Paclitaxel
    Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
  • Drug: Bevacizumab
    Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
  • Drug: Placebo
    Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Study Arms  ICMJE
  • Experimental: ONO-4538 group

    ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

    Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

    Interventions:
    • Drug: ONO-4538
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Bevacizumab
  • Placebo Comparator: Placebo group

    Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

    Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Bevacizumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
530
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
  • Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy
  • Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
  • Subjects who are able to provide tumor tissue specimens.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

  • Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations.
  • Subjects with known ALK translocations.
  • Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
  • Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
  • Subjects with multiple cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03117049
Other Study ID Numbers  ICMJE ONO-4538-52
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Naoki Sumiyoshi Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP