Clinical trial NCT05701787: Molecular Landscape Analysis and Clinical Implications for NSCLC Patients With Rare Mutations
Official title: Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
NSCLC Stage IV
NSCLC, Recurrent
Keywords: NSCLC
rare mutations
molecular landscape
next-generation sequencing (NGS)
targeted therapy
immunotherapy
chemotherapy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 20 years
measure: Disease control rate (DCR)
timeFrame: 20 years
measure: Progression-free survival (PFS)
timeFrame: 20 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 20 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaomin Niu
state: Shanghai
city: Shanghai
country: China
facility: Xiaomin Niu
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Xiaomin Niu
role: PRINCIPAL_INVESTIGATOR
References: