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

Sponsor

Shanghai Chest Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05701787

Collaborator

(none)

500

Enrollment

Locations

132

Anticipated Duration (Months)

250

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC NSCLC Stage IV NSCLC, Recurrent

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2029

Outcome Measures

Primary Outcome Measures

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
Progression-free survival (PFS) [20 years]
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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