Phase 3
N=550
Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03117049 ↗Enrolled (actual)
550
Serious AEs
49.6%
Results posted
Apr 2022
Primary outcome: Primary: Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC) — 12.1; 8.1 months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ONO-4538 (Drug); Carboplatin (Drug); Paclitaxel (Drug); Bevacizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Ono Pharmaceutical Co., Ltd.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC) |
12.1; 8.1 | <0.0001 sig |
| SECONDARY Overall Survival (OS) |
25.4; 24.7 | — |
| SECONDARY Objective Response Rate (ORR [as Assessed by the IRRC]) |
61.5; 50.5 | — |
| SECONDARY Disease Control Rate (DCR [as Assessed by the IRRC]) |
87.3; 89.8 | — |
| SECONDARY Duration of Response (DOR [as Assessed by the IRRC]) |
11.0; 7.0 | — |
| SECONDARY Best Overall Response (BOR [as Assessed by the IRRC]) |
14; 8; 155; 131; 71; 108 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03117049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.