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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4538 for squamous non-small-cell lung cancer (NSCLC) | Experimental | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4538 | Drug | ONO-4538 Study in Patients With Squamous NSCLC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (Centrally Assessed) | 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. | 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 | Description | Time Frame |
|---|---|---|
| Response Rate (Investigator-assessed) | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitsunobu Tanimoto | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goyang-si Clinical Site 103 | Goyang-si | Gyeonggi-do | South Korea | |||
| Seongnam-si Clinical Site 104 |
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Of 104 subjects determined eligible, 1 had an unknown histological type and excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Squamous Non-small Cell Lung Cancer (NSCLC) | In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg with 2-week dosing intervals for 6 weeks. 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. |
| FG001 | Non-squamous Non-small Cell Lung Cancer (NSCLC) | In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg with 2-week dosing intervals for 6 weeks. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Squamous Non-small Cell Lung Cancer (NSCLC) | Refer to "Participant Flow". |
| BG001 | Non-squamous Non-small Cell Lung Cancer (NSCLC) | Refer to "Participant Flow". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate (Centrally Assessed) | 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. | Full analysis set（FAS): This set was defined as a full group of subjects who were included in safety analysis set, which was defined as group of subjects who were enrolled and received at least one dose of the study drug. This set was used in the primary efficacy evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
|
From the start of the first dose of the investigational product to 28 days after the final dose or discontinuation, occurring 28 or fewer days after the final dose, or data cut-off point (June 2, 2015), whichever occurs first. Adverse events will be monitored and assessed before each dose and as needed based on clinical symptoms. Total assessment period: up to 10 months per participant.
The analysis was performed on SAS, which was defined as group of subjects who received at least one dose of the study drug. Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of study drug that first appeared following exposure to study drug or any event already presented that worsened relative to the pre-treatment state following the treatment. All-Cause Mortality was defined as incidence of TEAEs leading to death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Squamous Non-small Cell Lung Cancer (NSCLC) | Refer to "Participant Flow". | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Center | Ono Pharmaceutical Co., Ltd. | clinical_trial@ono-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2020 | Aug 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2021 | Sep 1, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ONO-4538 | Drug | ONO-4538 Study in Patients With Non-Squamous NSCLC |
|
|
| Overall Survival | 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. | 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. |
| Progression Free Survival (Centrally Assessed) | 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. | 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. |
| Duration of Response (Centrally Assessed) | 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. | 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. |
| Seongnam-si |
| Gyeonggi-do |
| South Korea |
| Cheongju-si Clinical Site 106 | Cheongju-si | North Chungcheong | South Korea |
| Incheon Clinical Site 102 | Incheon | South Korea |
| Seoul Clinical Site 101 | Seoul | South Korea |
| Seoul Clinical Site 107 | Seoul | South Korea |
| Seoul Clinical Site 108 | Seoul | South Korea |
| Seoul Clinical Site 109 | Seoul | South Korea |
| Seoul Clinical Site 110 | Seoul | South Korea |
| Ulsan Clinical Site 105 | Ulsan | South Korea |
| Met an exclusion criteria |
|
| Adverse Event |
|
| Disease progression |
|
| Other than above reasons |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Disease stage | Clinical stage was diagnosed according to UICC-TNM classification (7th edition) . Generally, the prognosis becomes worse as the stage progresses. | Count of Participants | Participants |
|
| Prior treatment for NSCLC: Surgery | Count of Participants | Participants |
|
| Prior treatment for NSCLC: Radiotherapy | Count of Participants | Participants |
|
| Prior treatment for NSCLC-Medication: Platinum-based chemotherapy | Count of Participants | Participants |
|
| Prior treatment for NSCLC-Medication: EGFR-TKI therapy | EGFR-TKI: epidermal growth factor receptor-tyrosine kinase inhibitors. | Count of Participants | Participants |
|
| Number of treatment regimens for NSCLC | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group performance status | PS 0 means "fully active, able to carry on all pre-disease performance without restriction" whereas PS 1 means "restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work". Generally, the prognosis worsens as PS worsens. | Count of Participants | Participants |
|
| Brain metastasis | Count of Participants | Participants |
|
| EGFR status | Count of Participants | Participants |
|
Refer to "Participant Flow".
| OG001 | Non-squamous Non-small Cell Lung Cancer (NSCLC) | Refer to "Participant Flow". |
|
|
| Secondary | Response Rate (Investigator-assessed) | 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. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | 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 | Overall Survival | 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. | FAS | Posted | Median | 95% Confidence Interval | days | 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. |
|
|
|
| Secondary | Progression Free Survival (Centrally Assessed) | 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. | FAS | Posted | Median | 95% Confidence Interval | days | 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. |
|
|
|
| Secondary | Duration of Response (Centrally Assessed) | 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. | FAS | Posted | Median | 95% Confidence Interval | days | 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. |
|
|
|
| 44 |
| 20 |
| 44 |
| 24 |
| 44 |
| EG001 | Non-squamous Non-small Cell Lung Cancer (NSCLC) | Refer to "Participant Flow". | 15 | 56 | 17 | 56 | 36 | 56 |
| Cardiac failure | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Sialoadenitis | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this tiral prior to submission for publication/presentation.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |