Phase 2
N=103
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
Advanced Non-small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT02175017 ↗Enrolled (actual)
103
Serious AEs
37.0%
Results posted
Dec 2024
Primary outcome: Primary: Response Rate (Centrally Assessed) — 13.6; 19.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ONO-4538 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Ono Pharmaceutical Co., Ltd.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Centrally Assessed) |
13.6; 19.6 | — |
| SECONDARY Response Rate (Investigator-assessed) |
18.2; 19.6 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Progression Free Survival (Centrally Assessed) |
67.0; 162.0 | — |
| SECONDARY Duration of Response (Centrally Assessed) |
NA; NA | — |
Summary
The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 20 years of age
- Histologically or cytologically confirmed non-small cell lung cancer
- Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
- Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)
Exclusion Criteria
- Current or prior severe hypersensitivity to another antibody product
- Multiple primary cancers
Data sourced from ClinicalTrials.gov (NCT02175017). 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.