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진행성 고형종양에서 유전체 변이에 기반한 분자 프로파일링 유도 요법에 대한 KPMNG 연구 II (KOSMOSII)

2026년 9월 29일 업데이트: Jee Hyun Kim, Seoul National University Bundang Hospital

진행성 고형종양의 유전체 변이에 기반한 분자 프로파일링 유도 요법에 대한 한국 정밀의학 네트워킹 그룹 연구 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)

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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

연구 유형

관찰

등록 (실제)

1000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대한민국
      • Bucheon-si, 대한민국
        • Soonchunhyang University Hospital Bucheon
      • Chungju, 대한민국
        • Chungbuk National University Hospital
      • Daegu, 대한민국
        • Keimyung University Dongsan Hospital
      • Daegu, 대한민국
        • Kyungpook National University Chilgok Hospital
      • Daegu, 대한민국
        • Yeungnam University Medical Center
      • Daejeon, 대한민국
        • Chungnam National University Hospital
      • Goyang, 대한민국
        • National Cancer Center
      • Hwasun, 대한민국
        • Chonnam National University Hwasun Hospital
      • Incheon, 대한민국
        • Gachon University Gil Medical Center
      • Incheon, 대한민국
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Jeonju, 대한민국
        • Jeonbuk National University Hospital
      • Jinju, 대한민국
        • Gyeongsang National University Hospital
      • Pusan, 대한민국
        • Dong-A University Hospital
      • Seongnam, 대한민국
        • Cha University Bundang Medical Center
      • Seongnam, 대한민국
        • Seoul National University Bundang Hospital
      • Seoul, 대한민국
        • Asan Medical Center
      • Seoul, 대한민국
        • Korea University Anam Hospital
      • Seoul, 대한민국
        • Korea University Guro Hospital
      • Seoul, 대한민국
        • Samsung Medical Center
      • Seoul, 대한민국
        • Seoul National University Hospital
      • Seoul, 대한민국
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Seoul, 대한민국
        • Gangbuk Samsung Hospital
      • Seoul, 대한민국
        • Hanyang University Hospital
      • Seoul, 대한민국
        • Chung-ang University Hospital
      • Seoul, 대한민국
        • Ewha womans university Mokdong Hospital
      • Seoul, 대한민국
        • The Catholic University of Korea, Seoul ST. Mary's Hospital
      • Seoul, 대한민국
        • Yonsei Cancer Hospital
      • Suwon, 대한민국
        • Ajou University Hospital
      • Suwon, 대한민국
        • The Catholic University of Korea, ST. Vincent's Hospital
      • Ulsan, 대한민국
        • Ulsan University Hospital
      • Wŏnju, 대한민국
        • Wonju Severance Christian Hospital
      • Yangsan, 대한민국
        • Pusan National University Yangsan Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

19년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.
의약품: Alectinib

ALK fusion or mutations, Mutations or amplification in any of the following: RET

다른 이름들:
  • 알레센사
의약품: 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)

다른 이름들:
  • 티센트릭
의약품: 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

다른 이름들:
  • 타세바
의약품: 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

다른 이름들:
  • 허셉틴 + 페르제타
의약품: 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

다른 이름들:
  • 캐싸일라
의약품: Vemurafenib

BRAF_V600E/D/K/R mutations

다른 이름들:
  • 젤보라프
의약품: Bevacizumab + Erlotinib

FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board

다른 이름들:
  • 아바스틴 + 타세바
의약품: 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

다른 이름들:
  • 로즐리트렉
의약품: 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

다른 이름들:
  • 가브레토
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Objective response rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Seoul National University Bundang Hospital

협력자

Roche Pharma AG
Korean Cancer Study Group

수사관

  • 연구 책임자: JEEHYUN KIM, Seoul National University Bundang Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 9월 28일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2022년 8월 29일

QC 기준을 충족하는 최초 제출

2022년 8월 30일

처음 게시됨 (실제)

2022년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KCSG AL 22-09

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다