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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Time frame
20 years
2

Disease control rate (DCR)

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Time frame
20 years
3

Progression-free survival (PFS)

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Time frame
20 years

Secondary outcomes

1

Overall survival (OS)

Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records

Time frame
20 years

Other outcomes

Sponsors and contacts

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