Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer

Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer Based on NGS Test Results in Hunan Province China

this study is to analyze the survival condition of different groups about non-small cell lung cancer patients with KRAS mutations。The groups are made according to the treatment regime,brain metastases and gene mutation

Study Overview

• Status: Enrolling by invitation
• Conditions: KRAS Gene Mutation Advanced Non-small Cell Lung Cancer
• Intervention / Treatment: Genetic: kras

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

the people who are advanced non-small cell lung cancer with KRAS mutation by NGS in Hunan province China

Description

Inclusion Criteria:

• advanced non-small cell lung cancer stage IIIB/IV
• KRAS mutation
• non-squmous

Exclusion Criteria:

• squmous non-small cell lung cancer

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohorts 1; Treatment plan
Cohorts 2; brain metastases
Cohorts 3; Concomitant KRAS mutation	Genetic: kras; the gene mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	Approximately 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression free survival	Approximately 1 years

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital
• Investigators: Principal Investigator: Yongchang Zhang, MD, zhangyongchang@csu.edu.cn

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: KILLER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No