Advanced Non-small Cell Lung Cancer
Conditions
Keywords
ONO-4538, Advanced non-small cell lung cancer
Brief summary
The objective of the study is to investigate the safety and efficacy 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.
Interventions
DRUGONO-4538
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG) | Approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (centrally assessed) | Approximately 6 months |
| Response rate (study site assessment by investigator) | Approximately 6 months |
| Overall survival | Approximately 1 year |
Countries
Taiwan
Outcome results
None listed