Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 5:37 PM
Study NCT ID:
NCT03085069
Status:
UNKNOWN
Last Update Posted:
2023-02-16
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210(Anti-PD-1 Antibody) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment.
Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(\<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks.
The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.
Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(\<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks.
The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.
Detailed Description:
In similar clinical trials, anti-PD-1 and anti-PD-L1 antibodies produce durable responses in approximately 20% of unselected patients with advanced non-small-cell lung cancer. Developing reliable, validated biomarkers that identify patients with an increased probability of response to these antibodies remains a challenge.
Because the PD-1 pathway may be a key mechanism of immune escape in a subgroup of patients with non-small-cell lung cancer, PD-L1 expression in tumor or inflammatory cells is a candidate biomarker. However, PD-L1 expression has not been formally validated as a biomarker in contemporaneously collected tumor tissue.
Additionally the purpose of the study is to assess the correlation between the expression of PD-L1 in the tumor and the response to treatment with SHR-1210 in non-small cell lung cancer.
Because the PD-1 pathway may be a key mechanism of immune escape in a subgroup of patients with non-small-cell lung cancer, PD-L1 expression in tumor or inflammatory cells is a candidate biomarker. However, PD-L1 expression has not been formally validated as a biomarker in contemporaneously collected tumor tissue.
Additionally the purpose of the study is to assess the correlation between the expression of PD-L1 in the tumor and the response to treatment with SHR-1210 in non-small cell lung cancer.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: