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Report for Clinical Trial NCT04306926

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

NCT04306926 Advanced Oligometastatic Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: TQB2450

Description: TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
Type: Drug
Group Labels: 1

TQB2450+SBRT

Name: SBRT

Description: Give according to the location of the lesion and clinical condition.
Type: Radiation
Group Labels: 1

TQB2450+SBRT


Primary Outcomes

Description: PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.

Measure: Progression-Free Survival (PFS)

Time: Baseline up to 96 weeks

Secondary Outcomes

Description: Percentage of subjects achieving complete response (CR) and partial response (PR).

Measure: Objective response rate (ORR)

Time: Baseline up to 96 weeks

Description: OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

Measure: Overall survival (OS)

Time: Baseline up to 96 weeks

Description: Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

Measure: Disease control rate(DCR)

Time: Baseline up to 96 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

2.Has mutations in (epidermal growth factor receptor)EGFR, (anaplastic lymphoma kinase)ALK, (c-ros oncogene 1 receptor kinase)ROS1 or T790M and not resistant to targeted drug. --- T790M ---



HPO Nodes


HPO: