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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.
Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGProgression-free Survival (PFS)
PFS is determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)
Overall Survival (OS)
OS is defined as the first date of treatment to date of death from any causes.
Time frame: up to approximately 36 months
PFS at 12 months (PFS12)
PFS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 12 months
PFS at 18 months (PFS18)
PFS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 18 months
OS at 12 months (OS12)
OS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 12 months
OS at 24 months (OS24)
OS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 24 months
OS at 36 months (OS36)
OS will be calculated using Kaplan-Meier product limit methods.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: up to approximately 36 months
Number of participants with AEs, SAEs, Treatment-related Adverse Events (TRAEs).
Time frame: From screening (Day -28) till final visit (up to a maximum of 24 months)