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This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706 to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EU Avastin® | Active Comparator | Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles |
|
| BAT1706 | Experimental | BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EU Avastin® | Drug | 100 mg/4 mL |
| |
| BAT1706 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The primary efficacy endpoint is ORR at Week 18 (ORR18) based on tumor response evaluated according to RECIST 1.1 as assessed by CIR. Each patient will be assigned to one of the following RECIST 1.1 categories based on independent CIR, irrespective of protocol deviations or missing data: CR: complete response. PR: partial response. SD: stable disease. PD: progressive disease. NE: not evaluable (insufficient data) | Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Rate | Progression free survival rate at 12 months, defined as the proportion of patients being alive without documented progression 12 months after randomization, using Kaplan-Meier method. | 8 months,1 year and 2 years |
| Progression Free Survival Time |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Level of Anti Drug Antibodies (ADA) and Neutralizing Anti-drug Antibodies (NADA) Correlated With Bevacizumab Plasma Level | Plasma level of anti drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level | 12 months |
| Bevacizumab Plasma Exposure Following Treatments of BAT1706 or EU Avastin® |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shengfeng Li | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | China | ||||
| Clinical Medical Research S.C. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EU Avastin® | Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles EU Avastin®: 100 mg/4 mL Paclitaxel: 200 mg/m² carboplatin: target area under the curve [AUC] 6 mg/mL•minute |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 20, 2019 | Aug 17, 2021 |
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| Drug |
100 mg/4 mL |
|
| Paclitaxel | Drug | 200 mg/m² |
|
| carboplatin | Drug | target area under the curve [AUC] 6 mg/mL•minute |
|
Progression free survival time defined as the time from the date of randomization to the date of documented clinical or radiological progression or death due to any cause using Kaplan-Meier method. |
| 8 months,1 year and 2 years |
| Overall Survival Rate | Overall survival rate at 12 months, defined as the proportion of patients being alive 12 months after randomization using Kaplan-Meier method. | 8 months,1 year and 2 years |
| Overall Survival Time | Overall survival time defined as the time from randomization to death of any cause using Kaplan-Meier method. | 8 months,1 year and 2 years |
| Overall Response Rate | ORR at Week 6 (ORR6) and ORR at Week 12 (ORR12), based on tumor response as assessed by CIR, and best ORR of confirmed responses at end of study assessed by local radiologist/Investigator if after Week 18 according to RECIST 1.1. | Week 6 and Week 12 |
| Duration of Response | Duration of response defined as the time from first documentation of a response (CR or PR) and the first documentation of progression (assessed by local radiologist/Investigator if after Week 18) according to RECIST 1.1. | 8 months |
Bevacizumab plasma exposure following treatments of BAT1706 or EU Avastin® |
| 12 months |
| Orizaba |
| 94300 |
| Mexico |
| National Hospital Oncology | Bloemfontein | 9301 | South Africa |
| Baskent University Ankara Hospital | Ankara | 6000 | Turkey (Türkiye) |
| CI Kryvyi Rih Oncological Dispensary of DRC | Kryvyi Rih | 53213 | Ukraine |
| FG001 | BAT1706 | BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles BAT1706: 100 mg/4 mL Paclitaxel: 200 mg/m² carboplatin: target area under the curve [AUC] 6 mg/mL•minute |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EU Avastin® | Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles EU Avastin®: 100 mg/4 mL Paclitaxel: 200 mg/m² carboplatin: target area under the curve [AUC] 6 mg/mL•minute |
| BG001 | BAT1706 | BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles BAT1706: 100 mg/4 mL Paclitaxel: 200 mg/m² carboplatin: target area under the curve [AUC] 6 mg/mL•minute |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Overall Response Rate | The primary efficacy endpoint is ORR at Week 18 (ORR18) based on tumor response evaluated according to RECIST 1.1 as assessed by CIR. Each patient will be assigned to one of the following RECIST 1.1 categories based on independent CIR, irrespective of protocol deviations or missing data: CR: complete response. PR: partial response. SD: stable disease. PD: progressive disease. NE: not evaluable (insufficient data) | Posted | Count of Participants | Participants | Week 18 |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival Rate | Progression free survival rate at 12 months, defined as the proportion of patients being alive without documented progression 12 months after randomization, using Kaplan-Meier method. | Not Posted | 8 months,1 year and 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival Time | Progression free survival time defined as the time from the date of randomization to the date of documented clinical or radiological progression or death due to any cause using Kaplan-Meier method. | Not Posted | 8 months,1 year and 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate | Overall survival rate at 12 months, defined as the proportion of patients being alive 12 months after randomization using Kaplan-Meier method. | Not Posted | 8 months,1 year and 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Time | Overall survival time defined as the time from randomization to death of any cause using Kaplan-Meier method. | Not Posted | 8 months,1 year and 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | ORR at Week 6 (ORR6) and ORR at Week 12 (ORR12), based on tumor response as assessed by CIR, and best ORR of confirmed responses at end of study assessed by local radiologist/Investigator if after Week 18 according to RECIST 1.1. | Not Posted | Week 6 and Week 12 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response defined as the time from first documentation of a response (CR or PR) and the first documentation of progression (assessed by local radiologist/Investigator if after Week 18) according to RECIST 1.1. | Not Posted | 8 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Plasma Level of Anti Drug Antibodies (ADA) and Neutralizing Anti-drug Antibodies (NADA) Correlated With Bevacizumab Plasma Level | Plasma level of anti drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Bevacizumab Plasma Exposure Following Treatments of BAT1706 or EU Avastin® | Bevacizumab plasma exposure following treatments of BAT1706 or EU Avastin® | Not Posted | 12 months | Participants |
From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
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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 | EU Avastin® | Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles EU Avastin®: 100 mg/4 mL Paclitaxel: 200 mg/m² carboplatin: target area under the curve [AUC] 6 mg/mL•minute | 4 | 324 | 119 | 324 | 8 | 324 |
| EG001 | BAT1706 | BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months. Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles BAT1706: 100 mg/4 mL Paclitaxel: 200 mg/m² carboplatin: target area under the curve [AUC] 6 mg/mL•minute | 7 | 325 | 119 | 325 | 9 | 325 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Gastrointestinal disorders | General disorders | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| General disorders and administration site conditions | Gastrointestinal disorders | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasms benign, malignant and unspecified (inclcysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Hepatobiliarydisorders | Hepatobiliary disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yufeng Zhang | Bio-Thera Solutions Ltd. | +86 2038251386 | yfzhang@bio-thera.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2019 | Aug 15, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| China |
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| Ukraine |
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| South Africa |
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| Mexico |
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