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This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP102, paclitaxel, carboplatin | Drug | BP102, paclitaxel, carboplatin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | optimal ORR at 18 weeks, independent radiographic assessment | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first. | 41 months |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210000 | China |
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BP102 in combination with paclitaxel/carboplatin compared with AvastinĀ® in combination with paclitaxel/carboplatin
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| AvastinĀ®, paclitaxel, carboplatin |
| Drug |
AvastinĀ®, paclitaxel, carboplatin |
|
Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.
| 41 months |
| Disease Control Rate (DCR) | Based on investigator reviewed radiographic tumour assessment and death. | 41 months |
| Duration of Response (DoR) | Based on investigator reviewed radiographic tumour assessment and death. | 41 months |
| Quality of Life assessment using EORTC QLQ-C30 | Evaluate subjects' quality of life | 41 months |
| Incidence of treatment-emergent adverse events, serious adverse events | Safety analyses will be performed using the safety population, defined as all patients receiving any study drug. | Enrollment to 28 days after permanent treatment termination |
| Positive rate of anti-bevacizumab antibody and its titer | Immunogenicity evaluation | 41 months |
| Positive rate of neutralizing antibody | Immunogenicity evaluation | 41 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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