KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II (KOSMOSII)

June 17, 2026 updated by: Jee Hyun Kim, Seoul National University Bundang Hospital

KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and/or immunotherapies outside of the approved indications via local clinical practice (Tier 1 & 2) and clinical trials (Tier 3)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A. The KOSMOS-II study will recruit locally advanced or metastatic solid tumor patients who had disease progression on standard first line anti-cancer treatment and/or has no standard treatment option, in order to prove MTB value to guide treatment within local clinical practice.

B. After site physicians confirm that NGS results of patients are available, they preliminarily decide initial treatment before MTB submission and collect informed consent form, and then patients can register to the KOSMOS-II study. Site physicians upload patients' clinical, pathologic, and genomic data for MTB submission. If site physician cannot determine initial treatment before MTB, site physician can record 'initial treatment cannot be determined' and can register the patient for MTB.

C. MTB records its treatment recommendations within available drugs list based on uploaded data, then site physicians make a final treatment decision, after informing patient about MTB decision and assessment of patients' final health status and preference.

D. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis.

E. Recommended treatment option There are three different options including (1) Tier 1: Therapeutic use of investigational products (KOSMOS-II drugs), (2) Tier 2: alternative treatment options, and (3) Tier 3: clinical trials

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Bucheon-si, South Korea
        • Recruiting
        • SoonChunHyang University Hospital Bucheon
        • Contact:
          • Jin-A Yun
      • Chungju, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
          • Yae-Won Yang
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Contact:
          • In-Hee Lee
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
          • Keon-Uk Park
      • Daegu, South Korea
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Ji-Yoon Jeong
      • Daejeon, South Korea
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • So-ra Kang
      • Goyang, South Korea
        • Recruiting
        • National Cancer Center
        • Contact:
          • Wonyoung Choi
      • Hwasun, South Korea
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
          • Sang Hee Cho
      • Incheon, South Korea
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
          • YoungSaing Kim
      • Incheon, South Korea
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Contact:
          • JaeHo Byun
      • Jeonju, South Korea
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
          • So-Yeon Jeon
      • Jinju, South Korea
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
          • Gyeong-Won Lee
      • Pusan, South Korea
        • Recruiting
        • Dong-A University Hospital
        • Contact:
          • Seok-Jae Huh
      • Seongnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Jee Hyun Kim
      • Seongnam, South Korea
        • Recruiting
        • CHA University Bundang Medical Center
        • Contact:
          • Beo-Deul Kang
      • Seoul, South Korea
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
          • Yong-Ho Noh
      • Seoul, South Korea
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Contact:
          • Kyung-Eun Lee
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Jin-Young Kim
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Tae-Yong Kim
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Min-Hee Ryu
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Eunju Kang
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
          • Se-Jun Park
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Jiwon Lee
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
        • Contact:
          • In-Sook Woo
      • Seoul, South Korea
        • Recruiting
        • Gangbuk Samsung Hospital
        • Contact:
          • Dong-Hoe Koo
      • Seoul, South Korea
        • Terminated
        • Hanyang University Hospital
      • Seoul, South Korea
        • Recruiting
        • Yonsei Cancer Hospital
        • Contact:
          • Min-Kyu Jung
      • Suwon, South Korea
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Mi-Sun Ahn
      • Suwon, South Korea
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
        • Contact:
          • Ho-Jung An
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:
          • Hyeon-Su Im
      • Wŏnju, South Korea
        • Terminated
        • Wonju Severance Christian Hospital
      • Yangsan, South Korea
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
          • Jung-Hoon Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Histologically proven locally advanced or metastatic solid tumor patients with disease progression on standard first line anti-cancer treatment and/or has no standard treatment option

Description

Inclusion Criteria:

  • 19 years of age or older

  • Histologically proven locally advanced or metastatic solid tumors*** who showed disease progression on standard first line anti-cancer treatment and/or has no standard treatment option

    *** very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval

  • A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial/study or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA.

    1. Results from genomic profiling tests performed after diagnosis with metastatic/advanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision.
    2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis.
  • Ability to understand and the willingness to sign a written informed consent document
  • Life expectancy of at least 12 weeks
  • Adequate recovery from most recent systemic or local treatment for cancer.

Exclusion Criteria:

  • Patients receiving any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment
  • Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient.
  • Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed.
  • Pregnant or breastfeeding, or intending to become pregnant during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
If there are no drugs available under current regulation or patients are not feasible to any clinical trials, and If tumors have actionable genetic alterations and approved drug in any indications but tumor type is not indicative, the MTB may recommend one of KOSMOS-II drugs, therapeutic use of investigational products.
Drug: Alectinib
ALK fusion or mutations, Mutations or amplification in any of the following: RET
Other Names:
  • Alecensa
Drug: Atezolizumab

MSI high status by any method Or Any mutation in any of these genes:

MLH1 or MSH2 or MSH6 or PMS2 or EPCAM Or Any of the following mutations in POLE: R150X, P286R, P286H, S297F, Y298fs, F367S, V411, L424V, P436R, S459F, R665W, L698fs, R762W, R1519C, R1826W, D316H, D316G, R409W, L474P Or Any of the following mutations in POLD1: P112fs, A930fs, S478N Or Any mutation in the following: POLE not listed above, POLD1 not listed above, POLD2, POLD3, POLD4, POLQ or PRKDC Or Any loss of function mutations in BRCA1, BRCA2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1, RFC2, RFC3, RFC4, RFC5, PCNA, RPA1, PRA2, PRA3, PRA4, or SSBP1 High tumor mutational burden decided by KOSMOS-II MTB (TMB ≥20/Mb in local NGS or if 10-20/Mb, confirmed by central NGS te sting)

Other Names:
  • Tecentriq
Drug: Erlotinib

EGFR Exon 19 deletions in the region E746_E759;

Any of the following EGFR mutations:

E709A, E709G, E709K, E884K, G719A, G719C, G719S, L858R, L861Q, L833V, S768I

Other Names:
  • Tarceva
Drug: Trastuzumab + Pertuzumab

ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:

G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y, L755S, p.L75 5_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 amplification or approved by the KOSMOS Molecular Tumor Board

Other Names:
  • Herceptin + Perjeta
Drug: Trastuzumab emtansine

ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:

G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y,L755S, p.L75 5_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 oncogenic mutations; G152V, X215_splice, D277Y, G292C, N302K, V308M, G309A, S310F, S310Y, S244C, L651V, V659E, G660D, R678Q, V697L, G727A, T733I, L755A, L755P, L755S, D769H, D769Y, A775_G776insSVMA, A775_G776insYVMA (i.e.,Y772_A775dup,M774_A775insAYVME 770delinsEAYVM), G776_V777 > AVCV, G776_V777 > AVGCV, G776_V777 > VCV, G776_V777insVC, G776C, G776delinsLCT, G776L, G776dleinsVC, G776L777_G778insC, V777L, V777M, G778_Y779insGSP, P780_Y781insGSP (i.e.,G778_P780dup), L786V, N813D, R840W, V842I, T862A, R896G, E1021Q or approved by the KOSMOS Molecular Tumor Board

Other Names:
  • Kadcyla
Drug: Vemurafenib
BRAF_V600E/D/K/R mutations
Other Names:
  • Zelboraf
Drug: Bevacizumab + Erlotinib
FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board
Other Names:
  • Avastin + Tarceva
Drug: Entrectinib
ROS1 gene fusion using either a fluo rescence in situ hybridization (FISH) or next-generation sequencing (NGS) or approved by the KOSMOS Molecular Tumor Board
Other Names:
  • Rozlytrek
Drug: Pralsetinib
RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board
Other Names:
  • Gavreto
Tier 2: Alternative treatments
If there are no KOSMOS-II drugs (Tier 1) or clinical trials (Tier 3) appropriate for patients, the MTB may recommend alternative treatment options (e.g., conventional therapy, radiotherapy, or supportive care).
Tier 3: Clinical trial
If patient is eligible for clinical trials matched for actionable genomic alterations found in NGS testing, the MTB will recommend enrollment to clinical trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the feasibility of molecular profiling guided therapies (MGT) based on genomic alterations in patients with advanced solid tumors in terms of the proportion of receipt of the treatment
Time Frame: 12 months after treatment initiation (estimated average)
Percentage of patients who receive molecular profiling guided therapy as recommended by MTB, either in therapeutic use of investigational products (KOSMOS-II drugs), alternative treatment, or clinical trial.
12 months after treatment initiation (estimated average)
To evaluate the effectiveness of molecular profiling guided therapies in terms of clinical benefit rate (CR/PR/SD beyond 16 +/- 2 weeks) in Tier 1* population
Time Frame: Assessed at 16 weeks of treatment
Percentage of patients achieving response defined as CR/PR/SD at 16 ± 2 weeks reported by site physician
Assessed at 16 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 12 months after treatment initiation (estimated average)
The proportion of patients who obtained CR/PR as the best response according to the RECIST 1.1 criteria
12 months after treatment initiation (estimated average)
Progression-free survival
Time Frame: 12 months after treatment initiation (estimated average)
Progression-free survival in accordance with local clinical practice
12 months after treatment initiation (estimated average)
Treatment duration
Time Frame: 12 months after treatment initiation (estimated average)
The period from the start of treatment to the end of treatment for any reason
12 months after treatment initiation (estimated average)
1-year overall survival rate
Time Frame: 12 months after treatment initiation (estimated average)
Proportion of patients alive 1 year after study registration
12 months after treatment initiation (estimated average)
To evaluate safety of molecular profiling guided therapies
Time Frame: 12 months after treatment initiation (estimated average)
The incidence of serious adverse events will be calculated among the adverse events in patients with Tier 1 and Tier 3. ( based on NCI-CTCAE v5.0 )
12 months after treatment initiation (estimated average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Roche Pharma AG
Korean Cancer Study Group

Investigators

  • Study Director: JEEHYUN KIM, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG AL 22-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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