Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non-Small Cell Lung Cancer
Age (in years)
20+
Phase
Phase 3
Participants needed
550
Est. Completion Date
May 31, 2024
Treatment type
Interventional
Sponsor
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov identifier
NCT03117049
Study number
ONO-4538-52
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