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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xiaomin Niu; Phone Number: 021-22200000; Email: ar_tey@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Xiaomin Niu
      • Contact: Xiaomin Niu; Phone Number: 3708 86 21 2220 0000; Email: ar_tey@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Participants with NSCLC with rare mutations are with the standard treatment and/or are enrolled in the clinical trials.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records	20 years

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Principal Investigator: Xiaomin Niu, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: chemotherapy; immunotherapy; NSCLC; targeted therapy; molecular landscape; rare mutations; next-generation sequencing (NGS)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: THORACIC003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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