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NCT05059951 Clinical Trial

ICI-combined Strategies Presented With Promising Efficacy in NSCLC Patients

Non Small Cell Lung Cancer Clinical Trial

Official title:
ICI-combined Strategies Presented With Promising Efficacy in NSCLC Patients With Non-EGFR Oncogenic Genetic Alterations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05059951
Other study ID # RARE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 1, 2021

Study information
Verified date January 2018
Source Hunan Province Tumor Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Due to insufficient data on immune checkpoint inhibitor (ICI)-combined strategies specialized for non-small cell lung cancer (NSCLC) patients with non-EGFR driver genes alterations. This retrospective study aimed to assess its efficacy in this subset of patients in the first and higher-line settings.

Recruitment information / eligibility
Status Completed
Enrollment 8425
Est. completion date March 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18,Advanced Non-small Cell Lung Cancer Confirmed by Histopathology Patients with non-EGFR driver gene alterations Treatment with immunotherapy Exclusion Criteria: - Patients with two or more driver gene alterations Patients with contraindication of chemotherapy Pregnant or breast feeding women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• immune checkpoint inhibitor-combined
Pembrolizumab and Sintilimab

Locations
Country Name City State
China Hunan Cancer Hospital Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Progression-free survival January 2018 to January 2021
Primary OS Overall survival January 2018 to January 2021
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