ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT02175017
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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)
- Current or prior severe hypersensitivity to another antibody product
- Multiple primary cancers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-4538 for squamous non-small-cell lung cancer (NSCLC) ONO-4538 In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase. ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC) ONO-4538 In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.
- Primary Outcome Measures
Name Time Method Response Rate (Centrally Assessed) 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. Response rate (%) = (Number of subjects whose confirmed best overall response was complete response (CR) or partial response (PR) / Total number of FAS)\*100. 95% Confidence interval (CI) was calculated by Wilson method.
- Secondary Outcome Measures
Name Time Method Response Rate (Investigator-assessed) 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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Overall Survival 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. Overall survival (days) = (the date of death due to any cause) - (the first dose date of investigational product) + 1. 95% CI was calculated by Kaplan-Meier method.
Progression Free Survival (Centrally Assessed) 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. Progression free survival (days) = (the earlier date of the first documented progressive disease (PD) or death due to any cause) - (the first dose date of investigational product) + 1. 95% CI was calculated by Kaplan-Meier method.
Duration of Response (Centrally Assessed) 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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Duration of response (days) = (the date of the first documented PD or death due to any cause after response was confirmed) - (the date of the first confirmed CR or PR) + 1. Median (95% CI) was calculated by Kaplan-Meier method.
Trial Locations
- Locations (10)
Ulsan Clinical Site 105
🇰🇷Ulsan, Korea, Republic of
Incheon Clinical Site 102
🇰🇷Incheon, Korea, Republic of
Seongnam-si Clinical Site 104
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul Clinical Site 109
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site 110
🇰🇷Seoul, Korea, Republic of
Cheongju-si Clinical Site 106
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Seoul Clinical Site 101
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site 108
🇰🇷Seoul, Korea, Republic of
Goyang-si Clinical Site 103
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul Clinical Site 107
🇰🇷Seoul, Korea, Republic of