Clinical trial NCT02175017: ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
Official title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)
Keywords: ONO-4538
Advanced non-small cell lung cancer (NSCLC)
nivolumab
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

1. Male or female ≥ 20 years of age
2. Histologically or cytologically confirmed non-small cell lung cancer
3. Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
4. Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

Exclusion Criteria:

1. Current or prior severe hypersensitivity to another antibody product
2. Multiple primary cancers

Primary outcomes:
measure: Response Rate (Centrally Assessed)
timeFrame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Secondary outcomes:
measure: Response Rate (Investigator-assessed)
timeFrame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
measure: Overall Survival
timeFrame: Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.
measure: Progression Free Survival (Centrally Assessed)
timeFrame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
measure: Duration of Response (Centrally Assessed)
timeFrame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Cheongju-si Clinical Site 106
state: Chungcheongbuk-do
city: Goyang-si
country: Korea, Republic of
facility: Goyang-si Clinical Site 103
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seongnam-si Clinical Site 104
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Incheon Clinical Site 102
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 101
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 107
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 108
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 109
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 110
city: Ulsan
country: Korea, Republic of
facility: Ulsan Clinical Site 105
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mitsunobu Tanimoto
role: STUDY_DIRECTOR
References: