Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: ONO-4538; Carboplatin; Paclitaxel; Bevacizumab; Placebo
Intervention description: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.; 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.; 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.; Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 550.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

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.
    

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.