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This is a phase II, open-Label, multi-centre study to determine the efficacy and safety of Camrelizumab plus apatinib in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiation therapy (cCRT) or sequential chemoradiation therapy (sCRT). This study will be conducted in China mainland.
This trial will evaluate the efficacy and safety of camrelizumab plus apatinib in participants with unresectable stage III NSCLC who have not progressed following definitive, platinum-based cCRT or sCRT. The primary endpoint is progression free survival (PFS) in the intent-to-treat (ITT) population. The secondary endpoints are as follows: 1) Overall survival (OS); 2) 1, 2, 3-year OS rates; 3) PFS rates at 12-monthand 18-month; 4) Objective response rate (ORR), 5) Duration of response (DoR); 6) Time to death or distant metastasis (TTDM); 7) Adverse effects (AEs) and severe adverse effects (SAEs) ;8) Quality of life (QoL).Exploratory objective is to explore potential biomarkers associated with efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Camrelizumab plus apatinib as consolidation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab, PD-1 monoclonal antibody | Drug | Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). | From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the first date of treatment to date of death from any causes. | up to approximately 36 months |
| PFS at 12 months (PFS12) | PFS will be calculated using Kaplan-Meier product limit methods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhouguang Hui | Contact | 18611876792 | drhuizg@163.com | |
| Yirui Zhai | Contact | 18610168510 | januarywind@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | 100021 | China |
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| Apatinib, VEGFR2 antibody | Drug | Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year. |
|
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| up to maximum 12 months |
| PFS at 18 months (PFS18) | PFS will be calculated using Kaplan-Meier product limit methods. | up to maximum 18 months |
| OS at 12 months (OS12) | OS will be calculated using Kaplan-Meier product limit methods. | up to maximum 12 months |
| OS at 24 months (OS24) | OS will be calculated using Kaplan-Meier product limit methods. | up to maximum 24 months |
| OS at 36 months (OS36) | OS will be calculated using Kaplan-Meier product limit methods. | up to maximum 36 months |
| Objective response rate (ORR) | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator. | up to approximately 24 months |
| Duration of Response (DoR) | DoR is defined as the first date of treatment to the progression, or the last evaluable assessment in the absence of progression. | up to approximately 24 months |
| TTDM | TTDM is defined as the first date of treatment to the first date of distant metastasis or death in the absence of distant metastasis. | up to approximately 36 months |
| Number of participants with AEs, SAEs, Treatment-related Adverse Events (TRAEs). | From screening (Day -28) till final visit (up to a maximum of 24 months) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| 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 |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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