Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
| |
| Placebo group 1 | Placebo Comparator |
| |
| Placebo group 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab | Drug | SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 (Stage I) | 2 years | |
| BIRC-assessed progression-free survival (PFS) as per RECIST v1.1(Stage II) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS)(Stage I) | 2 years | |
| Objective response rate (ORR)(Stage I) | 2 years | |
| Disease control rate (DCR) (Stage I) |
Not provided
Inclusion Criteria:
-
A subject must satisfy all of the following criteria to be considered for inclusion in the study:
Exclusion Criteria:
-
A subject who meets any of the following criteria will be excluded from study entry:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanchao Wang | Contact | 0518-81220278 | yuanchao.wang@hengrui.com | |
| You Li | Contact | 0518-81220278 | you.li.yl1@hengrui.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
Not provided
Not provided
Not provided
| Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin | Drug | Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin |
|
| Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin | Drug | Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin |
|
| 2 years |
| Duration of response (DOR) (Stage I) | 2 years |
| Overall survival (OS) (Stage I) | 2 years |
| Progression free survival (PFS)(Stage II) | 2 years |
| Objective response rate (ORR)(Stage II) | 2 years |
| Disease control rate (DCR)(Stage II) | 2 years |
| Duration of response (DOR) (Stage II) | 2 years |
| Overall survival (OS) (Stage II) | 2 years |
| Incidence and severity of adverse events (AEs), serious adverse events (Stage II) | 2 years |
| (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0(Stage II) | 2 years |
| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided