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| Name | Class |
|---|---|
| Betta Pharmaceuticals Co., Ltd. | INDUSTRY |
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This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.
This is a multicenter, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of mil60 plus paclitaxel and carboplatin versus bevacizumab plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.The primary objective of the study was to compare the Objective Response Rate according to RECIST 1.1 of mil60 in combination with paclitaxel plus carboplatin and bevacizumab plus paclitaxel plus carboplatin in the treatment of advanced or recurrent non-squamous NSCLC subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mil60 | Experimental | mil60 (15mg/kg) was co-administered intravenously with 4 to 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent mil60 (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal. |
|
| Bevacizumab | Active Comparator | Bevacizumab (15mg/kg) was co-administered intravenously with 4 to 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent mil60 (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mil60 | Drug | 15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Percentage of patients with complete remission or partial response | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Percentage of patients with complete remission or partial response | 26 months |
| Duration of response | Interval from the onset of a complete remission or partial response until evidence of disease progression or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute/Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China | |||
| Peking University Shenzhen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34841235 | Derived | Wan R, Dong X, Chen Q, Yu Y, Yang S, Zhang X, Zhang G, Pan Y, Sun S, Zhou C, Hong W, Zhao H, Yang L, Huang L, Wu R, Zang A, Ma R, Wu L, Lv D, Fu X, Han J, Li W, Duan J, Wang K, Jiang O, Chen Y, Guo Z, Gao H, Wen J, Wang S, Zhao E, Li G, Yue L, Liang L, Zeng A, Wang X, Zhu Y, Pan H, Dai Z, Feng W, Zhao G, Lin C, Li C, Li N, Bao Y, Li Y, Su Y, Zhao M, Fang H, Zhu Y, Zhang Y, Ding L, Wang Y, Yuan X, Wang J. Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study. EClinicalMedicine. 2021 Nov 19;42:101187. doi: 10.1016/j.eclinm.2021.101187. eCollection 2021 Dec. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | 15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg |
|
|
| 24 months |
| Progression-free survival | Interval between randomization and disease progression or death | 24 months |
| Disease control rate | Percentage of patients with complete remission, partial response and stable disease | 24 months |
| Overall survival | the time from randomisation to death from any cause | 30 months |
| Shenzhen |
| China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |