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
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy
This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab plus Apatinib | Experimental | Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | A human anti-PD-1 monoclonal antibody |
|
| 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). | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junling Li, PhD | Contact | 86-010-87788713 | drlijunling@vip.163.com | |
| Puyuan Xing | Contact | 86-010-87788713 | xingpuyuan@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34409776 | Derived | Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Apatinib | Drug | A tyrosine kinase inhibitor selectively targeting VEGFR-2 |
|
|
| Duration of Response |
Duration of Response, determined using RECIST v1.1 criteria |
| up to 1 year |
| Disease Control Rate (DCR) | Disease Control Rate, determined using RECIST v1.1 criteria | up to 1 year |
| Overall Survival (OS) | Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up | up to 2 years |
| Adverse Events (AEs) and Serious Adverse Events(SAEs) | The number of participants experiencing an AE and SAE will be assessed.Adverse | up to 1 year |
| QLQ-LC13 | Quality of Life questionnaire lung cancer module 13 | up to 1 years |
| EORTCQLQ-C30 | European Organization for Reasearch and Treatment of Cancer C30 | up to 1 years |