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Clinical Trials/NCT05701787
NCT05701787
Recruiting
Not Applicable

Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations

Shanghai Chest Hospital1 site in 1 country500 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
NSCLC
Sponsor
Shanghai Chest Hospital
Enrollment
500
Locations
1
Primary Endpoint
Progression-free survival (PFS)
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

Lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC).

Molecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), while there exists some other rare targetable mutation in NSCLC. Emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in NSCLC.

Different rare mutations with NSCLC have divergent clinical and therapeutic implications with a particular distinction. Therefore, there is an unmet need for more effective therapies for NSCLC with rare mutations. In summary, identification of genetic alterations in NSCLC with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with NSCLC with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2029
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaomin Niu

Principal Investigator

Shanghai Chest Hospital

Eligibility Criteria

Inclusion Criteria

  • Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C, RET fusion, NTRK fusion, etc.
  • 18 years of age or older
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: 20 years

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Objective response rate (ORR)

Time Frame: 20 years

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Disease control rate (DCR)

Time Frame: 20 years

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Secondary Outcomes

  • Overall survival (OS)(20 years)

Study Sites (1)

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