Description:
The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with
carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with
carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with
stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical
radiation in a multicenter, randomized, double-blind study.
Title
- Brief Title: Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
- Official Title: A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Clinical Trial IDs
- ORG STUDY ID:
ONO-4538-52
- NCT ID:
NCT03117049
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
ONO-4538 | | ONO-4538 group |
Carboplatin | | ONO-4538 group |
Paclitaxel | | ONO-4538 group |
Bevacizumab | | ONO-4538 group |
Placebo | | Placebo group |
Purpose
The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with
carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with
carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with
stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical
radiation in a multicenter, randomized, double-blind study.
Trial Arms
Name | Type | Description | Interventions |
---|
ONO-4538 group | Experimental | ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. | - ONO-4538
- Carboplatin
- Paclitaxel
- Bevacizumab
|
Placebo group | Placebo Comparator | Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. | - Carboplatin
- Paclitaxel
- Bevacizumab
- Placebo
|
Eligibility Criteria
Inclusion Criteria:
- Subjects with histologically- or cytologically-confirmed non-squamous non-small cell
lung cancer
- Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small
cell lung cancer unsuitable for radical radiation according to the UICC-TNM
Classification (7th edition) with no prior systemic anticancer therapy
- Subjects with at least one measurable lesion by radiographic tumor assessments per
RECIST 1.1 criteria
- Subjects who are able to provide tumor tissue specimens.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Exclusion Criteria:
- Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R)
substitution mutations.
- Subjects with known ALK translocations.
- Complication or history of severe hypersensitivity reactions to antibody products or
platinum-containing compounds
- Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
- Subjects with multiple cancer.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival (PFS) as assessed by the Independent Radiology Review Committee (IRRC) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | At least 3 years |
Safety Issue: | |
Description: | |
Measure: | PFS (as assessed by the study site's investigator) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR [as assessed by the IRRC and study site's investigator]) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR [as assessed by the IRRC and study site's investigator]) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR [as assessed by the IRRC]) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to response (TTR [as assessed by the IRRC]) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Best overall response (BOR [as assessed by the IRRC and study site's investigator]) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Maximum percentage of change in the sum of diameters of target lesions (as assessed by the IRRC) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Safety will be analyzed through the incidence of adverse events, serious adverse events |
Time Frame: | Up to 100 days from last dose |
Safety Issue: | |
Description: | |
Measure: | Patient reported outcome (PRO) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Ono Pharmaceutical Co. Ltd |
Last Updated
October 26, 2020