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Updated: Jul 6, 2026
Detecting Somatic Genetic Alterations in Tumor Specimens by Exon Capture and Massively Parallel Sequencing
Published on: October 18, 2013
Pragmatic nationwide master observational trial based on genomic alterations in advanced solid tumors: KOrean
Sun Young Kim1, Jee Hyun Kim2, Tae-Yong Kim3
1Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Background:
Next-generation sequencing (NGS) has been introduced to many Korean institutions to support molecular diagnostics in cancer since 2017, when it became eligible for reimbursement by the National Health Insurance Service. However, the uptake of molecularly guided treatment (MGT) based on NGS results has been limited because of stringent regulations regarding prescriptions outside of approved indications, a lack of clinical trial opportunities, and limited access to molecular tumor boards (MTB) at most institutions. The KOSMOS-II study was designed to demonstrate the feasibility and effectiveness of MGT, informed by MTBs, using a nationwide precision medicine platform.
Methods:
The KOSMOS-II trial is a large-scale nationwide master observational study. It involves a framework for screening patients with metastatic solid tumors for actionable genetic alterations based on local NGS testing. It recommends MGT through a remote and centralized MTB meeting held biweekly. MGT can include one of the following options: Tier 1, the therapeutic use of investigational drugs targeting genetic alterations such as ALK, EGFR, ERBB2, BRAF, FH, ROS1, and RET, or those with high tumor mutational burden; Tier 2, comprising drugs with approved indications or those permitted for treatment outside of the indications approved by the Health Insurance Review and Assessment Service of Korea; Tier 3, involving clinical trials matching the genetic alterations recommended by the MTB. Given the anticipated proportion of patients receiving MGT in the range of 50% ± 3.25%, this study aims to enroll 1,000 patients. Patients must have progressed to one or more lines of therapy and undergone NGS before enrollment.
Discussion:
This pragmatic master protocol provides a mass-screening platform for rare genetic alterations and high-quality real-world data. Collateral clinical trials, translational studies, and clinico-genomic databases will contribute to generating evidence for drug repositioning and the development of new biomarkers.
Trial Registration:
NCT05525858.
Insights
The KOSMOS-II study demonstrates a nationwide precision medicine platform for molecularly guided cancer treatment (MGT). This approach utilizes next-generation sequencing (NGS) and molecular tumor boards (MTBs) to improve patient care.
Area of Science:
- Oncology
- Genomics
- Precision Medicine
Background:
- Next-generation sequencing (NGS) is available in Korea for cancer diagnostics since 2017.
- Molecularly guided treatment (MGT) uptake is limited by regulations, lack of trials, and limited access to molecular tumor boards (MTBs).
- The KOSMOS-II study aims to address these limitations by evaluating MGT feasibility and effectiveness.
Purpose of the Study:
- To demonstrate the feasibility and effectiveness of molecularly guided treatment (MGT) informed by molecular tumor boards (MTBs).
- To establish a nationwide precision medicine platform for cancer patients.
Main Methods:
- A large-scale, nationwide master observational study (KOSMOS-II).
- Screening of metastatic solid tumor patients for actionable genetic alterations using local NGS testing.
- Recommendations for MGT through a remote, centralized MTB meeting, including investigational drugs, approved drugs, and clinical trials.
Main Results:
- The study aims to enroll 1,000 patients with metastatic solid tumors who have progressed on prior therapies.
- Anticipated proportion of patients receiving MGT is 50% ± 3.25%.
Conclusions:
- The KOSMOS-II pragmatic master protocol serves as a mass-screening platform for rare genetic alterations.
- It generates high-quality real-world data for drug repositioning and biomarker development.
- Supports collateral clinical trials and translational studies.
