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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05701787
Enrollment
500
Registered
2023-01-27
Start date
2019-01-01
Completion date
2029-12-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC, NSCLC, Recurrent, NSCLC Stage IV

Keywords

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

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.

Interventions

None listed

Sponsors

Shanghai Chest Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Objective response rate (ORR)20 yearsCollect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Disease control rate (DCR)20 yearsCollect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Progression-free survival (PFS)20 yearsCollect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Secondary

MeasureTime frameDescription
Overall survival (OS)20 yearsCollect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Countries

China

Contacts

Primary ContactXiaomin Niu
ar_tey@hotmail.com021-22200000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026