Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Collaborator: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Bevacizumab; Carboplatin; Nivolumab; Paclitaxel; Pharmaceutical Solutions

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.