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進行性固形腫瘍におけるゲノム変化に基づく分子プロファイリング誘導療法に関する KPMNG 研究 II (KOSMOSII)

2026年9月29日 更新者：Jee Hyun Kim、Seoul National University Bundang Hospital

Korean Precision Medicine Networking Group 進行性固形腫瘍におけるゲノム変化に基づく分子プロファイリング誘導療法の研究 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)

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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

研究の種類

観察的

入学 (実際)

1000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

19年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
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.
薬：Alectinib

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

他の名前：
  • アレセンサ
薬：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)

他の名前：
  • テセントリク
薬：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

他の名前：
  • タルセバ
薬：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

他の名前：
  • ハーセプチン + パージェタ
薬：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

他の名前：
  • カドチラ
薬：Vemurafenib

BRAF_V600E/D/K/R mutations

他の名前：
  • ゼルボラフ
薬：Bevacizumab + Erlotinib

FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board

他の名前：
  • アバスチン + タルセバ
薬：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

他の名前：
  • ロズリートレック
薬：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

他の名前：
  • ガブレト
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective response rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Seoul National University Bundang Hospital

協力者

Roche Pharma AG
Korean Cancer Study Group

捜査官

  • スタディディレクター：JEEHYUN KIM、Seoul National University Bundang Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年9月28日

一次修了 (推定)

2027年3月31日

研究の完了 (推定)

2027年3月31日

試験登録日

最初に提出

2022年8月29日

QC基準を満たした最初の提出物

2022年8月30日

最初の投稿 (実際)

2022年9月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • KCSG AL 22-09

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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