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

NCT05701787 | Recruiting DMC

• 1 other identifier: THORACIC003
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

NSCLC; NSCLC Stage IV; NSCLC, Recurrent

Keywords

NSCLC; rare mutations; molecular landscape; next-generation sequencing (NGS); targeted therapy; immunotherapy; chemotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Overall survival (OS)

  20 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• years of age or older
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• None

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (2)

Xiaomin Niu

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Xiaomin Niu

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaomin Niu

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomin Niu

CONTACT

021-22200000; ar_tey@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)