Clinical Trials /

Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer

NCT03117049

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer
  • Official Title: A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: ONO-4538-52
  • NCT ID: NCT03117049

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
ONO-4538ONO-4538 group
CarboplatinONO-4538 group
PaclitaxelONO-4538 group
BevacizumabONO-4538 group
PlaceboPlacebo group

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ONO-4538 groupExperimentalONO-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.
  • ONO-4538
  • Carboplatin
  • Paclitaxel
  • Bevacizumab
Placebo groupPlacebo ComparatorPlacebo: 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.
  • Carboplatin
  • Paclitaxel
  • Bevacizumab
  • Placebo

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) as assessed by the Independent Radiology Review Committee (IRRC)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:At least 3 years
Safety Issue:
Description:
Measure:PFS (as assessed by the study site's investigator)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:
Measure:Objective response rate (ORR [as assessed by the IRRC and study site's investigator])
Time Frame:Up to approximately 3 years
Safety Issue:
Description:
Measure:Disease control rate (DCR [as assessed by the IRRC and study site's investigator])
Time Frame:Up to approximately 3 years
Safety Issue:
Description:
Measure:Duration of response (DOR [as assessed by the IRRC])
Time Frame:Up to approximately 3 years
Safety Issue:
Description:
Measure:Time to response (TTR [as assessed by the IRRC])
Time Frame:Up to approximately 3 years
Safety Issue:
Description:
Measure:Best overall response (BOR [as assessed by the IRRC and study site's investigator])
Time Frame:Up to approximately 3 years
Safety Issue:
Description:
Measure: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 Issue:
Description:
Measure:Safety will be analyzed through the incidence of adverse events, serious adverse events
Time Frame:Up to 100 days from last dose
Safety Issue:
Description:
Measure:Patient reported outcome (PRO)
Time Frame:Up to approximately 5 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ono Pharmaceutical Co. Ltd

Last Updated

February 11, 2018