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

Recruiting

• Conditions: NSCLC; NSCLC Stage IV; NSCLC, Recurrent

• Registration Number: NCT05701787
• Lead Sponsor: Shanghai Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	20 years	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Objective response rate (ORR)	20 years	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Disease control rate (DCR)	20 years	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	20 years	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Trial Locations

Locations (1)

Xiaomin Niu; 🇨🇳 Shanghai, Shanghai, China