The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year. Explore objective is potential biomarker associated with efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 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: up to approximately 3 years
Overall Survival (OS)
OS is defined as the first date of treatment to date of death from any causes.
Time frame: up to approximately 5 years
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.
Time frame: up to approximately 1 years
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
Time frame: up to approximately 3 years
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed.
Time frame: up to 18 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 24 months (PFS24)
PFS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 24 months
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PFS at 5 years
PFS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 5 years
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 5 years
OS will be calculated using Kaplan-Meier product limit methods.
Time frame: up to maximum 5 years