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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701787
• Other study ID #: THORACIC003
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Shanghai Chest Hospital
• Contact: Xiaomin Niu
• Phone: 021-22200000
• Email: ar_tey[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• None

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC
• NSCLC Stage IV
• NSCLC, Recurrent

Locations

Country	Name	City	State
China	Xiaomin Niu	Shanghai	Shanghai
China	Xiaomin Niu	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records	20 years
Primary	Disease control rate (DCR)	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records	20 years
Primary	Progression-free survival (PFS)	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records	20 years
Secondary	Overall survival (OS)	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records	20 years